GE Healthcare Nuclear Medicine Systems Recalled for Potential Detector Fall Risk
GE Healthcare nuclear medicine imaging systems may have improper detector support following transport or relocation, potentially causing detector fall and life-threatening injury. The recall affects 36 systems distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving potential life-threatening injury from detector fall, but the source text indicates no actual injuries have been reported. The hazard is theoretical, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling certain nuclear medicine imaging systems, including the Infinia, VariCam, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 models. These systems are used in healthcare facilities for nuclear medicine imaging.
The systems could have been transported or relocated without proper detector support. When this occurs, excessive load can be applied to the detector mounting mechanisms. This could result in detector fall and life-threatening bodily injury.
The recall affects 36 units distributed worldwide.
The recalled product
- Product
- GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Hazard
- detector-fall
- mounting-failure
- bodily-injury
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)
- 1) 5178728: UDI/DI N/A
- System ID YN1200
- Serial Number: 16179
- System ID YN1650
- Serial Number: 17339. 2) H3000WE: UDI/DI N/A
- System ID 82426060010
- Serial Number Not Available
- System ID 82426080021
- System ID 82426090035
- Serial Number 18605
- System ID 82426090037
- Serial Number 18604
- System ID 82426100057
- Serial Number 19191
- System ID 82426150036
- Serial Number 18624
- System ID 82426150038
- System ID 82426180015
- Serial Number 18611
- System ID 082426010021
Distribution
Distribution scope not specified by the agency.
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