Open, ClassifiedPosted Sep 6, 2024·Initiated Jul 29, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Reason: The potential for biased quality control (QC) and
patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot
140 reagents.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Biuret (Colorimetric), Total ProteinDistribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, India, Ireland, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E., United Kingdom, Uruguay, Vatikancity.Recall #Z-3063-2024 Open, ClassifiedPosted Sep 6, 2024·Initiated Jul 29, 2024
ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
Reason: The potential for biased quality control (QC) and
patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot
140 reagents.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Biuret (Colorimetric), Total ProteinDistribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, India, Ireland, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E., United Kingdom, Uruguay, Vatikancity.Recall #Z-3064-2024 Open, ClassifiedPosted Sep 6, 2024·Initiated Jul 30, 2024
Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;
Reason: During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling line which led to some wells to underfill in lot 23206BA. Calibrator, quality control (QC) and patient results could have been impacted.
Root cause: Software Manufacturing/Software Deployment
Recalling firm: Siemens Healthcare Diagnostics, Inc.Type: Diazo Colorimetry, BilirubinDistribution: Domestic: Nationwide Distribution.
International: Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Qatar, Slovenia, Spain, Switzerland.Recall #Z-3065-2024 Open, ClassifiedPosted Sep 6, 2024·Initiated Aug 2, 2024
Brand Name: Vit-l-escence
Product Name: Vit-l-escence Singles A3
Model/Catalog Number: 1203-
Software Version: N/A
Product Description: Vit-l-escence composite is a light-cured, microhybrid, Bis-GMA esthetic composite restorative material. It is
75% filled by weight, 52% filled by volume with 0.7 m average particle size.
Dentin Shades: fluorescent properties to replicate natural dentin. Available in 18 dentin shades.
Enamel Shades: opalescent properties to replicate enamel. Available in 16 enamel shades including pearl,
translucent, and opaque shades.
Component: N/A
Reason: Due to a manufacturing issue, red particulates present in the expressed composite.
Root cause: Material/Component Contamination
Recalling firm: Ultradent Products, Inc.Type: Material, Tooth Shade, ResinDistribution: US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV
Foreign: NL, DE, CH, CZ, FR, ESRecall #Z-3066-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Aug 2, 2024
Brand Name: Transcend
Product Name: Transcend Econo Kit (UB) - Singles
Model/Catalog Number: 4817-
Software Version: N/A
Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be
used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is
radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61%
filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle
distribution.
Component: N/A
Reason: Due to a manufacturing issue, red particulates present in the expressed composite.
Root cause: Material/Component Contamination
Recalling firm: Ultradent Products, Inc.Type: Material, Tooth Shade, ResinDistribution: US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV
Foreign: NL, DE, CH, CZ, FR, ESRecall #Z-3067-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Aug 2, 2024
Brand Name: Transcend
Product Name: Transcend Singles Universal Body (UB) Refill 10pk
Model/Catalog Number: 4757-
Software Version: N/A
Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be
used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is
radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61%
filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle
distribution.
Component: N/A
Reason: Due to a manufacturing issue, red particulates present in the expressed composite.
Root cause: Material/Component Contamination
Recalling firm: Ultradent Products, Inc.Type: Material, Tooth Shade, ResinDistribution: US: AZ, CA,CO,FL,GA,HI, IA, ID,IL,IN,KS,KY,LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, SC, TN, TX, UT, VA, VT, WI, WV
Foreign: NL, DE, CH, CZ, FR, ESRecall #Z-3068-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Jun 18, 2024
CRANIOTOMY PACK, Pack Number DYNJ46552O
Reason: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: US: TX, IL, CARecall #Z-3069-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Jun 18, 2024
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
Reason: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: US: TX, IL, CARecall #Z-3070-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Jun 18, 2024
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377
Reason: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: US: TX, IL, CARecall #Z-3071-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Jun 18, 2024
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
Reason: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Root cause: Process change control
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Orthopedic TrayDistribution: US: TX, IL, CARecall #Z-3072-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated Jun 17, 2024
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Reason: A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
Root cause: Software change control
Recalling firm: Medtronic NeuromodulationType: Stimulator, Electrical, Implantable, For IncontinenceDistribution: US Nationwide distribution.Recall #Z-3073-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated May 9, 2024
Syringes with Fixed Needles labeled as:
a) SOL-M:
1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884;
2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593;
3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609;
4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
Reason: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Root cause: Other
Recalling firm: Sol-Millennium Medical Inc.Type: Syringe, PistonDistribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, PanamaRecall #Z-3074-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated May 9, 2024
Syringes with exchangeable needles labeled as:
SOL-CARE:
1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858;
2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865;
3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851;
4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950;
5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967;
6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974;
7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001;
8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018;
9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025;
10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032;
11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049;
12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063;
13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model
Reason: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Root cause: Other
Recalling firm: Sol-Millennium Medical Inc.Type: Syringe, PistonDistribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, PanamaRecall #Z-3075-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated May 9, 2024
Syringes with Luer Slip Tips labeled as:
1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138;
2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523;
3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998;
4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493;
5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462;
6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646;
7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636;
8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333;
9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340;
10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957
Reason: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Root cause: Other
Recalling firm: Sol-Millennium Medical Inc.Type: Syringe, PistonDistribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, PanamaRecall #Z-3076-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated May 9, 2024
Syringes with Eccentric Tips labeled as:
1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551;
2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605;
3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;
Reason: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Root cause: Other
Recalling firm: Sol-Millennium Medical Inc.Type: Syringe, PistonDistribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, PanamaRecall #Z-3077-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated May 9, 2024
Syringes with Low Dead Space labeled as:
a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899;
b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554;
c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1" (low dead space), Model No. 181023L, UPC Sold in Canada Only;
d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8" low dead space), Model No. 12558LDS, UPC 810062435319;
e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165;
f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only
Reason: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Root cause: Other
Recalling firm: Sol-Millennium Medical Inc.Type: Syringe, PistonDistribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, PanamaRecall #Z-3078-2024
Open, ClassifiedPosted Sep 6, 2024·Initiated May 9, 2024
Syringe Tip Caps labeled as:
1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A;
2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A;
3) SOL-M Red Cap, Model No. 110101150020, UPC N/A
4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A
Reason: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Root cause: Other
Recalling firm: Sol-Millennium Medical Inc.Type: Container, Liquid Medication, GraduatedDistribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, PanamaRecall #Z-3079-2024
Open, ClassifiedPosted Sep 5, 2024·Initiated Jul 16, 2024
Trilogy Evo EV300 --
Model Number/ Model Description:
BL2200X15B Trilogy Evo, O2, Benelux EV300;
BR2200X18B Trilogy Evo, O2, Brazil EV300;
CA2200X12B Trilogy Evo, O2, Canada EV300;
DE2200X13B Trilogy Evo, O2, Germany EV300;
DS2200X11B Trilogy Evo, O2, USA EV300;
DS2200X11B Trilogy Evo, O2, USA EV300;
EE2200X15B Trilogy Evo, O2, Eastern Europe EV300;
ES2200X15B Trilogy Evo, O2, Spain EV300;
EU2200X15B Trilogy Evo, O2, EU EV300;
FR2200X14B Trilogy Evo, O2, France EV300;
FX2200X15B Trilogy Evo, O2, INT EV300;
GB2200X15B Trilogy Evo, O2, Great Britain EV300;
IN2200X15B Trilogy Evo, O2, INTL EV300;
IT2200X21B Trilogy Evo, O2, Italy EV300;
KR2200X15B Trilogy Evo, O2, Korea EV300;
ND2200X15B Trilogy Evo, O2, Nordics EV300;
TR2200X15B Trilogy Evo, O2, Turkey EV300;
Reason: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Root cause: Device Design
Recalling firm: Philips Respironics, Inc.Type: Continuous, Ventilator, Home UseDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.Recall #Z-2942-2024
Open, ClassifiedPosted Sep 5, 2024·Initiated Jul 16, 2024
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Reason: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Root cause: Device Design
Recalling firm: Philips Respironics, Inc.Type: Ventilator, Continuous, Facility UseDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.Recall #Z-2943-2024
Open, ClassifiedPosted Sep 5, 2024·Initiated Jul 16, 2024
Trilogy Evo;
Model No./Model Description --
AU2110X15B Trilogy Evo, Australia
BL2110X15B Trilogy Evo, Benelux
BR2110X18B Trilogy Evo, Brazil
CA2110X12B Trilogy Evo, Canada
DE2100X13B Trilogy Evo O2, Germany
DE2110X13B Trilogy Evo, Germany
DS2100X11B Trilogy Evo, O2, USA
DS2110X11B Trilogy Evo, USA
DS2110X11B Trilogy Evo, USA
EE2100X15B Trilogy Evo O2, Eastern Europe
EE2110X15B Trilogy Evo, Eastern Europe
ES2100X15B Trilogy Evo O2, Iberia
ES2110X15B Trilogy Evo, Iberia
EU2100X15B Trilogy Evo, O2, EU
EU2100X19 Trilogy Evo, O2, EU (Non-BT)
EU2110X15B Trilogy Evo, EU
EU2110X19 Trilogy Evo, EU (Non-BT)
FR2100X14B Trilogy Evo O2, France
FR2110X14B Trilogy Evo, France
FX2100X15B Trilogy Evo, O2, INT
GB2110X15B Trilogy Evo, Great Britain
IA2100X15B Trilogy Evo O2, India
IA2110X15B Trilogy Evo, India
IN2100X15B Trilogy Evo, O2, International
IN2100X19 Trilogy Evo, O2, International (Non-BT)
IN2110X15B Trilogy Evo, International
IT2100X21B Trilogy Evo O2, Italy
IT2110X21B Trilogy Evo, Italy
JP2100X16B Trilogy Evo, O2, Japan
JP2110X16B Trilogy Evo, Japan
KR2110X15B Trilogy Evo, Korea
LA2100X15B Trilogy Evo, O2, Latin America
LA2110X15B Trilogy Evo, Latin America
LD2110X23B Garbin Evo, Linde
ND2100X15B Trilogy Evo O2, Nordics
ND2110X15B Trilogy Evo, Nordics
RDS2110X11B Trilogy Evo, USA-Rental
SP2100X26B LifeVentEVO2
TR2110X15B Trilogy Evo, Turkey
UDS2110X11B Trilogy Evo, USA-RECERT
VT2110X24B Aeris EVO
Reason: Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Root cause: Device Design
Recalling firm: Philips Respironics, Inc.Type: Continuous, Ventilator, Home UseDistribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: AU, BD, BE, BG, BO, BR, BS, CH, CL, NL, CN, CO, CZ, DE, DK, FR, SE, GB, GF, GR, GT, HK, HR, HU, IE, IL, IN, IT, JP, KE, KW, LB, LT, MA, ME, MA, MT, MQ, MX, NO, NP, OM, PA, PE, PF, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SI, SK, SG, TH, TN, TR, TW, UA, YT, ZA and ZW.Recall #Z-2944-2024