Recall Z-0544-2025— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2024-11-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Mammotrak Interventional Coil 3.0T. Reason: Potential safety issue where a patient may be harmed while preparing for or during a scan..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-04
- Firm location
- Cambridge, MA, United States
Product description
Mammotrak Interventional Coil 3.0T
Reason for recall
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Data sourced from openFDA. This site is unofficial and independent of the FDA.