25
Aug
2021

Recall – Adjusting CT scan patient preferences alters other characteristics

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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

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