FDAFDA · Food and drugs·Recall number Z-0544-2025
Mammotrak Interventional Coil 3.0T
Published December 4, 2024 · Recall initiated: November 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential safety issue where a patient may be harmed while preparing for or during a scan.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- US Nationwide distribution.
- Lot
- REF: 453530228891; UDI-DI: 00884838065857; Serial No. 73, 96, 58, 95, 119, 26, 16, 56, 94, 38, 28, 66, 135, 120, 2, 76.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.