Philips North America Recall 93787
Description: Intera 1.5T Achieva Nova, Model (REF) Numbers 781172
Philips North America Recall 93787 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0952-2024 |
| Event ID | 93787 |
| Event Description | Intera 1.5T Achieva Nova, Model (REF) Numbers 781172 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution. |
| Quantity | 15 US; 68 OUS |
| Recall Reason | The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury. |
| Device Classification | 20240207 |
| Device Code Info | Model No. 781172 UDI-DI N/A All units affected |
| Center Classification Date | 20240201 |
| Recall Initiation Date | 20240103 |
| Recalling Firm | Philips North America |
| Initial Notification | Letter |
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