Philips North America Llc: Medical Device Recall in 2022 - (Recall #: Z-0461-2023)

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

Product Classification:

Class II

Date Initiated: November 22, 2022
Date Posted: December 14, 2022
Recall Number: Z-0461-2023
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 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.

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated