Philips North America Llc: Device Recall
Recall #Z-0544-2025 · 11/04/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0544-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Philips North America Llc
- Status
- Ongoing
- Date Initiated
- 11/04/2024
- Location
- Cambridge, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,231 units
Reason for Recall
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Product Description
Mammotrak Interventional Coil 3.0T
Distribution Pattern
US Nationwide distribution.
Other Recalls by Philips North America Llc
- Class II: Risk 12/12/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
- Class II: Risk 10/31/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.