GE Optima NM/CT 640 Recalled for Loose Camera Fasteners
GE Healthcare is recalling 29 Optima NM/CT 640 systems because loose fasteners could cause the camera to fall onto a patient during a scan.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect (loose fasteners) that could cause a heavy component to fall on a patient, posing a risk of significant injury, which aligns with the 'Severe' criteria for structural defects or significant injury reports.
Plain-English summary
GE Healthcare, LLC is recalling 29 units of the Optima NM/CT 640 system, specifically Models H3100YA and H3100YC. These systems are used for general nuclear medicine imaging procedures and include a CT component for attenuation correction and anatomical localization.
The recall is being issued due to a potential safety issue where loose fasteners securing the camera to the gantry could cause a portion of the system to fall onto a patient during a scan. GE is updating its Preventative Maintenance procedure and schedule to include an additional check for loose fasteners on Nuclear Medicine systems.
The affected units were distributed worldwide, including the United States (nationwide, Guam, Puerto Rico, and DC) and numerous international countries. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- Optima NM/CT 640, Models H3100YA, H3100YC. 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…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 29
Distribution
Part of a larger recall action
This product is one of 6 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 6 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 · falling object
See all →- SevereLithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arms
CPSC · 2026-10-22
- HighMaquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk
FDA (Devices) · 2026-09-30
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- SevereTerex Digger Derrick Trucks Recalled for Weld Defect
NHTSA · 2026-08-17
Similar recalls
- CriticalGE Healthcare Recalls Optima NM/CT 640 Systems Due to Patient Death
FDA (Devices) · 2013-07-31
- HighGE Healthcare Recalls Optima NM/CT 640 Systems for Detector Screw Issue
FDA (Devices) · 2019-05-08
- HighGE Healthcare Recalls Optima NM/CT 640 Due to Loose Rotor Bearing Screws
FDA (Devices) · 2021-01-20
- HighGE Healthcare Nuclear Medicine Systems Recalled Due to Detector Fall Risk
FDA (Devices) · 2025-01-22
- CriticalGE Nuclear Medicine Imaging Systems detector fall hazard
FDA (Devices) · 2023-02-15
- CriticalGE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
FDA (Devices) · 2013-07-31