Infinia Nuclear Medicine Systems Detector Motion Risk from Software Defect
Certain Infinia nuclear medicine systems may experience unintended detector motion during patient setup or scanning if the gantry software is not up to date, potentially causing serious 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 medical device recall. The source text identifies potential for life-threatening injury from unintended detector motion but does not report any actual injuries or hospitalizations. Per the rubric, this qualifies as High (Score 3) for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Medical Systems Israel is recalling Infinia, Infinia Hawkeye, Infinia II, and Infinia II Hawkeye 4 nuclear medicine systems. The recalled units are identified by specific serial numbers and have been distributed worldwide, including throughout the United States.
Unintended detector motion may occur during patient setup or scanning if the system does not have the correct version of gantry software installed. This unintended motion could result in life-threatening injury to patients or staff. The defect affects specific serial numbers as identified in the recall.
Healthcare facilities should verify whether they operate an affected system by checking their equipment's serial number against the manufacturer's recall information.
The recalled product
- Product
- Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Hazard
- unintended-detector-motion
- injury-risk
- software-defect
Distribution
Distributed nationwide across the United States.
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