GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling Varicam/VG and VG Hawkeye devices after a patient died from injuries sustained during a scan at a US VA Medical Center.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 while being scanned on the device. Per the rubric, if reported deaths exist anywhere in the source text, the score is 5 regardless of other factors.
Plain-English summary
GE Healthcare, LLC is recalling 571 units of Varicam/VG and VG Hawkeye devices, including the Infinia Hawkeye 4 Nuclear Medicine System. These devices are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body.
The recall was initiated after GE became aware of an incident at a VA Medical Center facility in the US where a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
The affected devices were distributed worldwide, including the US nationwide, Guam, Puerto Rico, and numerous international countries. Consumers and healthcare facilities should contact GE Healthcare for further instructions regarding the recall and replacement or repair of the affected units.
The recalled product
- Product
- GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by…
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 571
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: 2998
- 6970
- 12865
- 21414
- 38070
- 53263
- 55461
- 56948
- 58230
- 58378
- 58379
- 58483
- 58510
- 58582
- 58622
- 58630
- 58711
- 58785
- 58797
- 58808
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
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
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 Optima NM/CT 640 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
Similar recalls
- HighGE Healthcare Recalls Varicam and VG Hawkeye Imaging Devices
FDA (Devices) · 2014-03-19
- HighGE Healthcare Recalls Varicam and VG Hawkeye Nuclear Medicine Devices
FDA (Devices) · 2014-11-19
- HighGE Healthcare Recalls Infinia Nuclear Medicine Systems for Detector Motion Risk
FDA (Devices) · 2014-03-19
- SevereGE Healthcare Recalls Infinia Nuclear Medicine Systems Due to Mechanical Failure Risk
FDA (Devices) · 2013-04-17
- HighGE Healthcare Recalls Nuclear Medicine Systems Due to Collimator Detachment Risk
FDA (Devices) · 2015-03-25
- HighGE Healthcare nuclear medicine imaging systems recalled for detector fall risk
FDA (Devices) · 2025-01-22