Recall Z-0291-2026— GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Name: FDA recall Z-0291-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Class II · Ongoing

Class II FDA medical device recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, initiated 2025-09-12. It names one FDA 510(k) clearance: K884674. Product: Elscint Model 4XX; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging. 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..

Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Classification: Class II
Status: Ongoing
Initiated: 2025-09-12
Firm location: Haifa, Israel

510(k) clearances named in this recall

1 on FDA's record

K884674 — APEX 415 ANGER CAMERAElscint, Inc.·cleared 1989-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.