Recall Z-1341-2020 ยท ITX Transducer, Ultrasonic, Diagnostic
Hitachi Medical Systems America Inc
UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
| Date | Jan 31, 2020 |
| Status | Terminated |
| Reason | These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings. |
| Root cause | Process change control |
| Action | On January 31, 2020, the firm initiated customer communications via Urgent Medical Device Recall letters. Customers were informed of the potential mis-wiring issue. Clinicians are advised to discontinue use of the probes to minimize adverse events. Hitachi Service will contact each affected site to schedule a service visit. Hitachi will test all affected probes and remove and replace any probes that do not pass the test. The correction is expected to begin February 2020. |
| Quantity | 18 |
| Distribution | Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada. |
| FDA record | Open on fda.gov |