Philips North America Llc: Medical Device Recall in 2022 - (Recall #: Z-0459-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2022.
Data Source: FDA.
Product Description:
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Product Classification:
Class II
Date Initiated: November 22, 2022
Date Posted: December 14, 2022
Recall Number: Z-0459-2023
Event ID: 91195
Reason for Recall:
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Status: Ongoing
Product Quantity: 566 total
Code Information:
Model 781357: UDI-DI: 00884838088108; Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071; Model 782106: UDI-DI: 00884838098329; Serial Numbers: 46224 46225 46265 46269 46311; Model Number 782137: UDI-DI: 00884838108615; Serial Numbers: Included in Letter but No Devices Distributed in the US.
Distribution Pattern:
US Nationwide.
Voluntary or Mandated:
Voluntary: Firm initiated