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

Brilliance 64, Computed Tomography X-ray system — recall Z-2116-2016

U.S. FDA — Device Enforcement · United States · 2016-04-01 · Class II

As described by U.S. FDA — Device Enforcement: Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2116-2016
Date of alert
2016-04-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Medical Systems (Cleveland) Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
Reported risk: Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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