Recall Z-0960-2022 ยท ITX Transducer, Ultrasonic, Diagnostic
Huntleigh Healthcare Ltd.
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
| Date | Feb 11, 2022 |
| Status | Terminated |
| Reason | Faceplate may become detached from the probe body. |
| Root cause | Under Investigation by firm |
| Action | The firm notified their consignees by email beginning on 02/11/2022. The notice explained the issue and requested disposal of the probes on site. Distributors were directed to notify their customers. The firm will replace the affected probes. |
| Quantity | 150 devices |
| Distribution | US Nationwide distribution in the states of OK, CA, GA, MI, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201425 | Disposable Intraoperative Probe (DIOP8) Huntleigh Healthcare Limited, Feb 19, 2021 |