Z-1341-2020 Class II Terminated
FDA device recall Z-1341-2020 was initiated by Hitachi Medical Systems America Inc on January 31, 2020 and is designated Class II. 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. The recall status is terminated (terminated July 31, 2020). Affected quantity: 18.
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