FDA Device recall Z-1775-2025
Intera 1.5T Explorer/Nova Dual, Model Number: 781108
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of Intera 1.5T Explorer/Nova Dual, Model Number: 781108 by Philips Medical Systems Nederland B V, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1775-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-24 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Nederland B V |
| Distribution | US |
Product
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
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.
Identifiers
| code_info | Model Number (REF): 781108; UDI-DI: N/A; All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1775-2025%22
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