GE Healthcare Recalls Optima NM/CT 640 Systems Due to Patient Death
GE Healthcare is recalling 25 Optima NM/CT 640 systems worldwide after a patient died from injuries sustained during a scan on a related system.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that a patient died due to injuries sustained during a scan, which meets the rubric criterion for a score of 5 (Critical) due to known fatalities.
Plain-English summary
GE Healthcare, LLC is recalling 25 units of the Optima NM/CT 640 system. These systems are intended for general nuclear medicine imaging procedures to detect radioisotope tracer uptake in the patient body. The recall covers units distributed worldwide, including the United States, Guam, Puerto Rico, and numerous international locations.
The recall was initiated after GE became aware of an incident at a US VA Medical Center where a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. GE notified hospitals that they are recalling several nuclear medicine imaging systems because serious injuries or deaths could occur due to the failure mode associated with this recall.
Hospitals and facilities with these systems should contact GE Healthcare for further instructions regarding the recall and potential remediation of the identified failure mode.
The recalled product
- Product
- Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scannin
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- System ID: 0910263253
- 0910263256
- 00139NUC08
- 00162NUC11
- 030232NU15
- 215728OPT640
- 262574O640
- 270956NM640
- 410543NUC640
- 715735OPT1
- 717782640NM
- 808485NM640
- 815564O640
- 816234D640
- 817250NM640
- 847872O640
- 901516GO640
- 915839NU01
- 928214NMCT
- A5366308
Distribution
Part of a larger recall action
This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- HighSIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
FDA (Devices) · 2022-07-27
Same hazard · patient death
See all →- CriticalGE Healthcare Recalls Infinia Hawkeye 4 Gamma Cameras Due to Patient Death
FDA (Devices) · 2013-07-31
- CriticalGE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
FDA (Devices) · 2013-07-31
- CriticalGE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
FDA (Devices) · 2013-07-31
- CriticalGE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
FDA (Devices) · 2013-07-31