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

Recall Z-0545-2016 — Brilliance iCT Computed Tomography X-ray system

U.S. FDA — Device Enforcement · United States · 2015-10-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0545-2016
Date of alert
2015-10-29
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: Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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