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Recall Observatory FDA recall evidence

Device product

Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

Z-0291-2026

September 12, 2025

Class II

Product summary

Firm
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Event
Event 97647
Status
Ongoing
Classification
Class II
Quantity
64 units
Official record key
device-enforcement:Z-0291-2026

Official wording

Reason: 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.

Code information: all serial numbers in distribution

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.