Z-2723-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- July 27, 2015
- Termination Date
- July 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 5 units
Product Description
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
Reason for Recall
Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
Code Information
Serial Numbers: HQC8FMV2142, HQC8FMV2143, HQC8FMV2144, HQC8FMV2145, HQC8FMV2146