FDA Enforcement
Class II
Ongoing
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Recall: Z-0459-2023
·
Reported December 14, 2022
Enforcement
- Recall Number
- Z-0459-2023
- Event ID
- 91195
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 14, 2022
- Initiation Date
- November 22, 2022
- Classification Date
- December 8, 2022
- Address
- 222 Jacobs St, N/A, Cambridge, MA, 02141-2289, United States
Description
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Reason
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Code Info
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
US Nationwide.
Quantity
566 total