Z-1341-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2020
- Initiation Date
- January 31, 2020
- Termination Date
- July 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18
Product 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.
Reason for Recall
These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
Distribution Pattern
Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.
Code Information
Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206H26224, 206H2625, 206H2626, 206H2627, 205X3897, 205X3898, 205X3899, and 205X3900