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

Recall Z-0522-2018 — Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system

U.S. FDA — Device Enforcement · United States · 2017-11-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0522-2018
Date of alert
2017-11-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Reported risk: One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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