Company: Philips North America LLC
Date of Enforcement Report: 8/25/2021
Class II
PRODUCT
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Recall Number: Z-2314-2021
REASON
When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.
RECALLING FIRM/MANUFACTURER
Philips North America LLC on 6/8/2021. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
U.S. Nationwide