[pending] Millenium MG/MC; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Pending LLM rewrite. Source: FDA_DEVICE Z-0297-2026.
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: Pending LLM scoring against the rubric.
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
- Millenium MG/MC; 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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