GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c)

FDA device recall Z-1056-2023 · posted 2023-02-08 · Open, Classified

Recall details

Recalling firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Reason for recall

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Action taken

GE Healthcare issue an URGENT MEDICAL DEVICE CORRECTION on 12/19/2022 by mail. The notice explained the issue and the risk, and requested the following action by taken: .GE Healthcare asks that you STOP USE of your Nuclear Medicine system, if your system is listed in the Affected Product Details and Appendix of this letter, until an inspection of your system is completed by GE Healthcare and you have been provided with a letter indicating the system can be returned to clinical use. .GE Healthcare will correct all affected products at no cost to you. GE Healthcare will inspect your system to ensure that the appropriate mitigation is correctly implemented to address this potential life-threatening concern. A GE Healthcare representative will contact you to arrange for this correction. .If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Process control

Status

Open, Classified

Product code

KPS

Quantity affected

34 units

Distribution

Worldwide distribution. US nationwide including Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, C

Date initiated

2022-12-19

Date posted

2023-02-08

Location

Tirat Carmel, Israel

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