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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING: Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

Medical DevicesSource: FDA (device) · Date: 2025-10-29

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Product
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide
Recall initiated
2025-09-12
Code info
all serial numbers in distribution
Product quantity
15 units
Voluntary mandated
Voluntary: Firm initiated
City
Haifa
Country
Israel
Event id
97647
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