Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0296-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
The recalled product
- Product
- Maxicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Category
- Medical Device — Devices
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 (1)
- all serial numbers in distribution
Distribution
Distribution scope not specified by the agency.
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