Home / Recalls / Philips North America Llc / Z-2314-2021

Z-2314-2021 Class II Terminated

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type: Devices
Report Date: August 25, 2021
Initiation Date: June 8, 2021
Termination Date: August 10, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 units

Product Description

728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

Reason for Recall

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.

Distribution Pattern

US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.

Code Information

S/N UDI: 87013 (01)00884838059474(21)87013 87008 (01)00884838059474(21)87008 87011 (01)00884838059474(21)87011 Software Version 4.1.10 SynchRight Option

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Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
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