Open, ClassifiedPosted Feb 28, 2025·Initiated Feb 3, 2025
Brand Name: TBS Osteo
Product Name: TBS iNsight
Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi
Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0
Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management
Component: No
Reason: Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.
Root cause: Software Design Change
Recalling firm: Medimaps GroupType: Densitometer, BoneDistribution: Domestic: AL, AZ, CA, CO, DE, FL, IL, LA, MA, MD, MI, MN, MO, MS, NC, NM, NY, OH, PA, SC, TX, UT, WA.
International: ALGERIA, ANDORRA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, CHILE, COLOMBIA, COSTA RICA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, SOUTH KOREA, LEBANON, MALAYSIA, MEXICO, MONTENEGRO, MOROCCO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAYRecall #Z-1250-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Oct 18, 2024
human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
Reason: The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.
Root cause: Process control
Recalling firm: HUMAN MED AGType: System, Suction, Lipoplasty For RemovalDistribution: US Nationwide distribution in the state of FL.Recall #Z-1251-2025
Open, ClassifiedPosted Feb 28, 2025·Initiated Apr 4, 2024
Philips IntelliSpace Cardiovascular software, Model 830089.
Reason: Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Root cause: Software design
Recalling firm: Philips Medical Systems Nederland B.V.Type: System, Image Processing, RadiologicalDistribution: US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.Recall #Z-1252-2025
Open, ClassifiedPosted Feb 27, 2025·Initiated Jan 30, 2025
Brand Name: Leica Biosystems Cryostats
Product Name: CM1950
Model/Catalog Number: 1491950C4US
Software Version: firmware V3.01
Reason: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue.
Root cause: Under Investigation by firm
Recalling firm: LEICA BIOSYSTEMS NUSSLOCH GMBHType: Microtome, CryostatDistribution: Worldwide - US Nationwide distribution in the states of Idaho and Ohio. The countries of France, Australia, Belgium, China, Germany, Spain, UK, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Poland, Singapore.Recall #Z-1247-2025
Open, ClassifiedPosted Feb 27, 2025·Initiated Jan 15, 2025
ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
Reason: Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes.
Root cause: Labeling False and Misleading
Recalling firm: TERRAGENE S.A.Type: Indicator, Biological Sterilization ProcessDistribution: US Nationwide distribution in the states of CA and KY.Recall #Z-1248-2025 Open, ClassifiedPosted Feb 26, 2025·Initiated Feb 3, 2025
VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
Reason: Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.
Root cause: Component change control
Recalling firm: Ventec Life Systems, Inc.Type: Ventilator, Continuous, Facility UseDistribution: US distribution in CA, NY, and MO.Recall #Z-1196-2025
Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 2, 2025
Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001
The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
Reason: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Scientia Vascular, Inc.Type: Catheter, Thrombus RetrieverDistribution: U..S. Nationwide distribution in the states of AL, AZ, FL, GA, HI, IL, IN, KS, MN, NC, NJ, NY, PA, SD, TX, VA, WI and WV.Recall #Z-1234-2025
Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 16, 2025
Plato 17 Microcatheter REF PL17-160-090
To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
Reason: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
Root cause: Under Investigation by firm
Recalling firm: Scientia Vascular, Inc.Type: Catheter, Percutaneous, NeurovasculatureDistribution: U.S. Nationwide distribution in the state of DE.Recall #Z-1235-2025
Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 29, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract
Model: EC38-i20cL
Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Root cause: Device Design
Recalling firm: Pentax of America IncType: Endoscope, Accessories, Image Post-Processing For Color EnhancementDistribution: NationwideRecall #Z-1236-2025 Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 29, 2025
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract
Model: EG29-i20c
Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Root cause: Device Design
Recalling firm: Pentax of America IncType: Endoscope, Accessories, Image Post-Processing For Color EnhancementDistribution: NationwideRecall #Z-1237-2025 Open, ClassifiedPosted Feb 26, 2025·Initiated Jan 29, 2025
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation.
Model: EPK-i8020c
Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes.
Root cause: Device Design
Recalling firm: Pentax of America IncType: Endoscope, Accessories, Image Post-Processing For Color EnhancementDistribution: NationwideRecall #Z-1238-2025 Open, ClassifiedPosted Feb 25, 2025·Initiated Feb 3, 2025
LIFEPAK 20e REF 99507-000001
The AED mode is to be used only on patients in cardiopulmonary arrest.
Reason: Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Root cause: Employee error
Recalling firm: Physio-Control, Inc.Type: Automated External Defibrillators (Non-Wearable)Distribution: U.S.: WV
O.U.S.: N/ARecall #Z-1232-2025 Open, ClassifiedPosted Feb 25, 2025·Initiated Jan 10, 2025
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Reason: Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
Root cause: Software change control
Recalling firm: BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.Type: Analyzer, Chemistry (Photometric, Discrete), For Clinical UseDistribution: US: MA, CA, SC, LA, OK, GA, AL, TX, OR, ID, CO, MN, NY, MS, PA, WA, IL, MI, PR.
OUS: Lebanon, Poland, Ghana, Spain, South Africa, Slovakia, Ghana, Croatia, Seychelles, Australia, Republic of KoreaRecall #Z-1233-2025
Open, ClassifiedPosted Feb 24, 2025·Initiated Jan 23, 2025
BD Alaris Pump Module REF 8100
The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration
Reason: Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Pump, InfusionDistribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Guantanamo Bay, Cuba
O.U.S.: CanadaRecall #Z-1231-2025
Open, ClassifiedPosted Feb 21, 2025·Initiated Jan 10, 2025
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Reason: Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.
Root cause: Labeling design
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: US Nationwide distribution including in the states of AZ, FL, NJ, KY, GA, CA, IL, MD, WI, OH, NC, MS, NY, MO, PA, OR, IN, TX, UT, OK, MI, WA, AL, NV, ME, WV, NE, DC, MA, MT, KS, CO, TN, IA, MN, AR, ID, SC, SD, CT, HI, VA, ND, AK, NM, VT, LA, WY.Recall #Z-1206-2025
Open, ClassifiedPosted Feb 21, 2025·Initiated Jan 23, 2025
BD Pyxis MedFlex 2.0 REF 1139-00
Bio-ID Spare Parts REF 353200-01
The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.
Reason: Due to fingerprint scanner failing resulting in the scanner heating up.
Root cause: Nonconforming Material/Component
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, and WY. The countries of Australia, Bahrain, Belgium, Brazil, Canada, Hong Kong, Kuwait, Lebanon, New Zealand, Qatar, Saudi Arabia, Spain, and Thailand.Recall #Z-1207-2025
Open, ClassifiedPosted Feb 21, 2025·Initiated Feb 5, 2025
IntelePACS (Image Fusion Module) - InteleViewer
Reason: A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.
Root cause: Software design
Recalling firm: INTELERAD MEDICAL SYSTEMS INCORPORATEDType: System, Image Processing, RadiologicalDistribution: Worldwide - US Nationwide distribution in the states of AZ, NC, MI, FL, NH, WY, CA, SC, AL, AR, IN, MD, CO, TN, IL, NJ, OH, MN, WV, KE, NE, VA, WA, GE, WI and the countries of New Zealand, Canada, AustraliaRecall #Z-1208-2025
Open, ClassifiedPosted Feb 21, 2025·Initiated Jan 21, 2025
A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708041
Reason: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Root cause: Process control
Recalling firm: Tyber MedicalType: Plate, Fixation, BoneDistribution: NationwideRecall #Z-1209-2025
Open, ClassifiedPosted Feb 21, 2025·Initiated Jan 21, 2025
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right
Model/Catalog Number: 770708042
Reason: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Root cause: Process control
Recalling firm: Tyber MedicalType: Plate, Fixation, BoneDistribution: NationwideRecall #Z-1210-2025
Open, ClassifiedPosted Feb 21, 2025·Initiated Jan 21, 2025
A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708061
Reason: Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Root cause: Process control
Recalling firm: Tyber MedicalType: Plate, Fixation, BoneDistribution: NationwideRecall #Z-1211-2025