Recall
FDAHealthSeptember 12, 2025

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

⚠️ 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.

Is this relevant to me?

Geography
Unknown
Source agency
FDA
Category
Health
Published
September 12, 2025

Worldwide

What's affected?

Product
Elscint Varicam; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
Lot code
all serial numbers in distribution

Additional details

all serial numbers in distribution

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 15 units.

View original FDA notice →

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