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

GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; Emission Computed Tomograph — recall Z-1055-2023

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1055-2023
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

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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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