Recall Z-0538-2025 ยท MOS Coil, Magnetic Resonance, Specialty
Philips North America Llc
dS Breast 16ch 3.0T
| Date | Nov 25, 2024 (initiated Nov 4, 2024) |
| Status | Open, Classified |
| Reason | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| Root cause | Use error |
| Action | 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. |
| Quantity | 5,231 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072873 | LBS-63-16 BREAST ARRAY COIL Invivo, Nov 16, 2007 |