Device product
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.
Z-1341-2020
Product summary
- Event
- Event 84838
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18
- Official record key
device-enforcement:Z-1341-2020
Official wording
Reason: These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
Code information: Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206H26224, 206H2625, 206H2626, 206H2627, 205X3897, 205X3898, 205X3899, and 205X3900
Distribution pattern: Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.
Derived failure modes
-
Unknown
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.