FDA Device recall Z-0949-2024
Achieva XR. Model (REF) Numbers 781153, 781253
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of Achieva XR. Model (REF) Numbers 781153, 781253 by Philips North America, 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-0949-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-03 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Achieva XR. Model (REF) Numbers 781153, 781253.
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 | a. Model No. 781153; UDI-DI N/A. b. Model No. 781253; UDI-DI N/A. All units affected |
|---|
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-0949-2024%22
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