Open, ClassifiedPosted Sep 17, 2024·Initiated Jul 24, 2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
Reason: Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled.
Root cause: Process control
Recalling firm: ROi CPS LLCType: Angiography/Angioplasty KitDistribution: US Nationwide distribution in the state of North Carolina.Recall #Z-3159-2024
Open, ClassifiedPosted Sep 17, 2024·Initiated Jul 23, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers:
a) 2110344-008;
b) 2110344-009;
c) 2110344-010;
d) 2110344-011;
e) 2110344-013;
f) 2110344-019;
g) 2110344-025;
h) 2110344-029;
i) 2110344-030;
j) 2110344-032
; Radiological image processing system
Reason: Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers.
" Internet Explorer 10 (IE10)
" Internet Explorer 11 (IE11)
" Firefox.
Root cause: Software Design Change
Recalling firm: GE HealthcareType: System, Image Processing, RadiologicalDistribution: Worldwide distribution.Recall #Z-3160-2024 Open, ClassifiedPosted Sep 17, 2024·Initiated Jul 26, 2024
BiomarC EX Fiducial Marker System, Catalog Number 040165
Reason: This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.
Root cause: Employee error
Recalling firm: Carbon Medical Technologies, Inc.Type: Accelerator, Linear, MedicalDistribution: US Nationwide distribution in the state of TN.Recall #Z-3161-2024
Open, ClassifiedPosted Sep 17, 2024·Initiated Aug 1, 2024
Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
Reason: Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).
Root cause: Component design/selection
Recalling firm: Btt Health GmbhType: Exerciser, PoweredDistribution: US Nationwide distribution in the states of Florida.Recall #Z-3162-2024
Open, ClassifiedPosted Sep 17, 2024·Initiated Aug 14, 2024
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151
i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
Reason: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
Root cause: Device Design
Recalling firm: Innovasis, IncType: Intervertebral Fusion Device With Bone Graft, LumbarDistribution: U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.Recall #Z-3163-2024
Open, ClassifiedPosted Sep 17, 2024·Initiated Jun 25, 2024
1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile;
2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile;
3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile;
4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile;
5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile;
6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile;
7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile;
8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile;
9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile;
10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;
Reason: The tube may fall into the surgical site during the grasping process.
Root cause: Device Design
Recalling firm: UNIMAX MEDICAL SYSTEMS INCType: Laparoscope, General & Plastic SurgeryDistribution: US Nationwide distribution in the states of GA, MO, and PA.Recall #Z-3164-2024
Open, ClassifiedPosted Sep 16, 2024·Initiated Aug 6, 2024
General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
Reason: The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
Root cause: Process control
Recalling firm: Cypress Medical Products LLCType: Syringe, PistonDistribution: US Nationwide distribution in the states of CA, NV, NY.Recall #Z-3154-2024
Open, ClassifiedPosted Sep 16, 2024·Initiated Aug 29, 2024
stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Reason: One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Root cause: Under Investigation by firm
Recalling firm: Tornier, IncType: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedDistribution: US Nationwide distribution in the states of IL, WI, AZ, NV, SD.Recall #Z-3155-2024
Open, ClassifiedPosted Sep 16, 2024·Initiated Jul 17, 2024
Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
Reason: Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.
Root cause: Device Design
Recalling firm: Mazor Robotics LtdType: Orthopedic Stereotaxic InstrumentDistribution: US Nationwide distribution in PR.Recall #Z-3156-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 15, 2024
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Root cause: Process control
Recalling firm: CareFusion 303, Inc.Type: Pump, InfusionDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.Recall #Z-3138-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 15, 2024
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Root cause: Process control
Recalling firm: CareFusion 303, Inc.Type: Pump, InfusionDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.Recall #Z-3139-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 15, 2024
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Root cause: Process control
Recalling firm: CareFusion 303, Inc.Type: Pump, InfusionDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.Recall #Z-3140-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 15, 2024
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Root cause: Process control
Recalling firm: CareFusion 303, Inc.Type: Pump, InfusionDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.Recall #Z-3141-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 15, 2024
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
Root cause: Process control
Recalling firm: CareFusion 303, Inc.Type: Pump, InfusionDistribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, 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, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.Recall #Z-3142-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 12, 2024
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).
Reason: During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues.
- Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2
- Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls
- Seer Home Systems were distributed with labeling deficiencies
Root cause: Under Investigation by firm
Recalling firm: SEER MEDICAL PTY LTDType: Full-Montage Standard ElectroencephalographDistribution: Worldwide - US Nationwide distribution in the states of MN, NY, PA and the countries of Australia.Recall #Z-3143-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 8, 2024
AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
Reason: Potential for product leakage from the Spin Lock Connector on the distal end of the device due to the migration of excess solvent during the assembly process.
Root cause: Process change control
Recalling firm: B. Braun Medical, Inc.Type: Set, Administration, IntravascularDistribution: US Nationwide distribution.Recall #Z-3144-2024 Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 8, 2024
ViewPoint; system, imaging processing, radiological
Reason: The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
Root cause: Device Design
Recalling firm: GE Healthcare GmbHType: System, Image Processing, RadiologicalDistribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.Recall #Z-3145-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Aug 8, 2024
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
Reason: The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
Root cause: Device Design
Recalling firm: GE Healthcare GmbHType: System, Image Processing, RadiologicalDistribution: US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.Recall #Z-3146-2024
Open, ClassifiedPosted Sep 13, 2024·Initiated Jul 18, 2024
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Root cause: Packaging process control
Recalling firm: Boston Scientific CorporationType: Tube, Drainage, SuprapubicDistribution: US, Colombia, Philippines, RussiaRecall #Z-3147-2024 Open, ClassifiedPosted Sep 13, 2024·Initiated Jul 18, 2024
Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
Reason: There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Root cause: Packaging process control
Recalling firm: Boston Scientific CorporationType: Tube, Drainage, SuprapubicDistribution: US, Colombia, Philippines, RussiaRecall #Z-3148-2024