FDA recall Z-0463-2023
Philips North America Llc · Class II · device
Product
Philips Upgrade to MR 7700 System, Model Number 782130
Reason for recall
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Distribution
US Nationwide.
Key facts
- Status
- Ongoing
- Initiation date
- 2022-11-22
- Report date
- 2022-12-14
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Cambridge, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0463-2023