Z-0461-2023 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
December 14, 2022
Initiation Date
November 22, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
566 total

Product Description

Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

Reason for Recall

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

Distribution Pattern

US Nationwide.

Code Information

Model 782118: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782132: Serial Numbers: Included in Letter but No Devices Distributed in the US. Model Number 782144: Serial Numbers: Included in Letter but No Devices Distributed in the US.