FDAFDA · Food and drugs·Recall number Z-0548-2025
ST SENSE Breast Dx Coil
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: 453530264791; UDI-DI: 00884838066823; Serial No. 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, 54.
- 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.