GE Healthcare nuclear medicine imaging systems recalled for detector mounting risk
GE Healthcare is recalling Discovery NM/CT nuclear medicine imaging systems that may fail if transported improperly. Unsupported detectors risk mounting mechanism failure and detector fall, potentially causing life-threatening injury.
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 with potential for life-threatening bodily injury. However, no reported injuries or illnesses are mentioned in the source, and the hazard is preventable through proper handling. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
GE Healthcare is recalling certain Discovery NM/CT 670 DR and related nuclear medicine imaging systems. The affected models include Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, and Optima NM/CT 640. A total of 76 units were distributed worldwide.
These systems may have been transported or relocated without proper detector support. When this occurs, excessive load is applied to the detector mounting mechanisms, potentially resulting in detector fall and life-threatening bodily injury.
The detector mounting mechanism failure poses a serious safety risk in clinical environments where patients and staff could be affected.
The recalled product
- Product
- GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Hazard
- detector-fall
- structural-damage
- improper-handling
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) 5376204-70-56-2: UDI/DI N/A
- System IDNT7007
- Serial Number NT2JG1800001
- UDI/DI N/A
- System IDNT4014
- Serial Number T2HG1700003/ 158624HL7
- System IDNT4017
- Serial Number 157120HL7
- System IDNT7001
- Serial Number 156620HL7
- System IDNT7005
- Serial Number 159731HL9. 2) H2401AW: UDI/DI 840682140898
- System ID N/A
- Serial Number NT2JG1800004
- UDI/DI 840682140898
- Serial Number NT2JG1800005
- Serial Number NT2JG1800006
- Serial Number NT2JG1800007
- Serial Number NT2JG1800008
- Serial Number NT2JG1800009
Distribution
Distribution scope not specified by the agency.
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