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Official recall record

Millenium Myosight; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

US FDA — Medical Devices · 2025-09-12 · IsraelClass II
Issuing authority
US FDA — Medical Devices
Alert date
2025-09-12
Country of alert
Israel
Alert level
Class II
Alert type
recall
Brand on record
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · Israel · all filters

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