FDAFDA · Food and drugs·Recall number Z-0541-2025
Mammotrak Diagnostic Coil 1.5T
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: 453530228872; UDI-DI: 00884838066762; Serial No. 79, 124, 71, 179, 124, 182, 45, 43, 178, 171, 181, 53, 40, 52, 69, 187, 95.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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