GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

Recall number

Z-1055-2023

Recalling firm

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Product

GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomography System

Status

Open, Classified

Initiated

2022-12-19

Posted

2023-02-08

Terminated

not on file

Reason

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

Root cause

Process control

Action

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.

Quantity

7 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, Cyprus, Czech Republic, Denmark, Egypt, El Salvador, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Libya, Lithuania, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uzbekistan, and Vietnam.

Lot, serial or model codes

a) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1900001BH; b) BRIVO 615 3/8 inch: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG2000002BH; c) BRIVO B615 3/8 inch DHP BJG NR: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG2000001BH; d) B615 with new rotor: Catalog number 5376204-16, UDI/DI To be provided, Serial Numbers: NT2QG1900002BH; e) BRIVO B615 3/8 inch BJG: Catalog number 5376204-16, UDI/DI Not Applicable, Serial Numbers: NT2QG1800001BH; f) BRIVO B615 3/8 inch DHP BJG NR: Catalog number H2402MP, UDI/DI To be provided, Serial Numbers: 00000168527HL0; g) B615 with new rotor: Catalog number To be provided, UDI/DI Not Applicable, Serial Numbers: NT2QG2000003BH;

510(k) numbers

K113350

PMA numbers

not on file

Product code

KPS

Firm FEI

3004571294

Firm city

Tirat Carmel

Firm state

not on file

Firm country

Israel

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy