Mammotrak Interventional Coil 3.0T
FDA device recall Z-0544-2025 · posted 2024-11-25 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Potential safety issue where a patient may be harmed while preparing for or during a scan.
- Action taken
- An URGENT MEDICAL DEVICE CORRECTION notice dated 10/31/24 was mailed to consignees. Consignees are to continue using affected systems in accordance with the intended use. When using the system follow section PRECAUTIONS, CAUTIONS & WARNINGS in the Instructions For Use (IFU). Consignees are to circulate the recall notice to all users for their awareness of the potential issue. The Recall Response Form is to be provided back to Philips MR within 30 days at Philips.Recall@philips.com. Customers with any questions are to contact their local Philips Representative.
- Root cause
- Use error
- Status
- Open, Classified
- Product code
- MOS
- Quantity affected
- 5,231 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2024-11-04
- Date posted
- 2024-11-25
- Location
- Cambridge, MA
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