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

Recall Z-0367-2014 — GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 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 for the evaluation

U.S. FDA — Device Enforcement · United States · 2013-10-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0367-2014
Date of alert
2013-10-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0910263235
Reported risk: GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/or Optima NM/CT 640, and/or Discovery NM630, and/or Brivo NM 615 all configurations) and the Patient's elbow may occur during SPECT protocols using 450 angular steps in scenarios when a Patients a
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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