FDAFDA · Food and drugs·Recall number Z-0546-2025
SENSE Breast Coil 3.0T 7ch
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: 453530089302; UDI-DI: 00884838065413; Serial No. 16, 7, 22, 52.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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