Medical Device Jun 12, 2024
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Class II FDA: Ongoing Olympus Corporation of the Americas
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Due to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices.
Class II FDA: Ongoing Verathon, Inc.
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when…
Class III FDA: Ongoing Ortho-Clinical Diagnostics, Inc.
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to…
Class II FDA: Ongoing MEDLINE INDUSTRIES, LP - Northfield
Medical Device Jun 12, 2024
Reports of patient burns.
Class I FDA: Ongoing Megadyne Medical Products, Inc.
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation
Medical Device Jun 12, 2024
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Class II FDA: Ongoing Atrium Medical Corporation