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

Recall Z-1054-2023 — GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense

U.S. FDA — Device Enforcement · Israel · 2022-12-19 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1054-2023
Date of alert
2022-12-19
Country / jurisdiction
Israel
Risk level
Class I
Risk type
recall
Brand
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840682140829
Reported risk: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading 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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