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

Recall Z-2193-2015 — GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

U.S. FDA — Device Enforcement · United States · 2015-07-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2193-2015
Date of alert
2015-07-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
453567971891
Reported risk: Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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