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

Recall Z-1791-2012 — The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipm

U.S. FDA — Device Enforcement · United States · 2012-05-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1791-2012
Date of alert: 2012-05-07
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: Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest sc

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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