Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0295-2026 — Elscint Helix; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

U.S. FDA — Device Enforcement · Israel · 2025-09-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0295-2026
Date of alert
2025-09-12
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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