Z-0459-2023 Class II Ongoing
FDA device recall Z-0459-2023 was initiated by Philips North America Llc on Nov 22, 2022 and is designated Class II. Reason for recall: Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. The recall status is ongoing. Affected quantity: 566 total.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 14, 2022
- Initiation Date
- Nov 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 566 total
Product Description
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
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 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0459-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026