FDAFDA · Food and drugs·Recall number Z-0542-2025
Mammotrak Interventional 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: 453530228882; UDI-DI: 00884838066779; Serial No. 69, 82, 143, 64, 77, 87, 76, 81, 134, 124, 141, 103, 135, 138, 73, 72, 131.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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