FDA recall Z-0544-2025
Philips North America Llc · Class II · device
Product
Mammotrak Interventional Coil 3.0T
Reason for recall
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-11-04
- Report date
- 2024-12-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Cambridge, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0544-2025