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.
Recall
- Recall Number
- Z-1341-2020
- Event Number
- 84838
- Firm
- Hitachi Medical Systems America Inc
- FEI Number
- 1528028
- Product Code
- ITX
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- January 31, 2020
- Terminated
- July 31, 2020
- Address
- 1959 Summit Commerce Park, Twinsburg, OH, 44087-2371
Description
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.
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
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.
Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.
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