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

Recall Z-1792-2013 — Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function f

U.S. FDA — Device Enforcement · United States · 2013-06-13 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1792-2013
Date of alert
2013-06-13
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0828260021
Reported risk: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this re
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.