Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device...
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Numb...
Due to product exhibiting potential to generate either invalid or false negative results.
Cub Pediatric Crib, Model FL19H
Cribs sold in the USA are missing two access door warning labels.
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Drainable large pouch may leak due to manufacturing issue.
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a de...
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software...
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfe...
Due to adapter not being properly aligned or locked in place.
Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device ...
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS...
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Numb...
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Drainable large pouch may leak due to manufacturing issue.
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
GEM Premier 5000 PAK; Part No. 00055407510.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Owner's Booklets and Instructions for Use that are used with the following blood...
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.
GEM Premier 5000; Model No. 00055430010.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
GEM Premier 5000 PAK; Part No. 00055415004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI...
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010
Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.
Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X...
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog...
Impactor handle may be missing cross-pin
Artelon FlexBand Plus Ref: 41054 & 41057
Augmentation devices failed bacterial endotoxin testing.
Penner Pacific Bathing Spa, Model Numbers 360020-1P
The device does not bear a unique device identifier.
GEM Premier 5000; Part No. 00055430011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.