GE Healthcare Nuclear Medicine Systems Recalled for Detector Fall Risk
GE Healthcare is recalling 859 units of nuclear medicine imaging systems that may have been transported improperly, risking detector failure and potential life-threatening injury from detector falls.
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 risk-of-harm from potential detector falls described in the source as capable of causing life-threatening injury. No incidents have been reported, placing this in the 'risk-of-harm products without reported injury' category per the severity rubric.
Plain-English summary
GE Healthcare is recalling 859 units of certain nuclear medicine imaging systems, including the Discovery NM/CT 670, Discovery NM 630, Brivo NM 615, Infinia, VariCam/VG/VH, and Optima NM/CT 640 models. These systems were distributed worldwide.
The recalled systems may have been transported or relocated without proper detector support. When systems are moved without adequate support, excessive load can be applied to the detector mounting mechanisms, potentially causing the detector to fall. A detector fall poses a risk of life-threatening bodily injury to patients or staff in proximity to the equipment.
No injuries or deaths have been reported related to this issue. The FDA has classified this as a Class II recall. The recalling manufacturer is GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING.
The recalled product
- Product
- GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Hazard
- detector-fall
- trauma-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) 5376204-70-54-2: UDI/DI N/A
- System ID NT1030
- Serial Number T27G16017/ 133897HL9
- UDI/DI N/A
- System ID NT4004
- Serial Number T27G15008/ 128542HL8
- System ID NT4008
- Serial Number T27G16019/ 134674HL1
- System ID NT4007
- Serial Number T27G16018/ 134286HL4
- System ID NT4009
- Serial Number T27G16016/ 133646HL0
- System ID NT1021
- Serial Number T27G1700031/ 147750HL4
- System ID NT4010
- Serial Number T27G16020/ 134675HL8
- System ID NT4012
- Serial Number T27G1700032/ 148489HL8
- System ID NT4001
- Serial Number T27G15002/ 122818HL8
Distribution
Distribution scope not specified by the agency.
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