Device product
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Z-0960-2022
Product summary
- Event
- Event 89580
- Status
- Terminated
- Classification
- Class II
- Quantity
- 150 devices
- Official record key
device-enforcement:Z-0960-2022
Official wording
Reason: Faceplate may become detached from the probe body.
Code information: Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)
Distribution pattern: US Nationwide distribution in the states of OK, CA, GA, MI, VA.
Derived failure modes
-
Unknown
Faceplate may become detached from the probe body.