Device product
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
Z-2723-2015
Product summary
- Event
- Event 71907
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 5 units
- Official record key
device-enforcement:Z-2723-2015
Official wording
Reason: 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.
Code information: Serial Numbers: HQC8FMV2142, HQC8FMV2143, HQC8FMV2144, HQC8FMV2145, HQC8FMV2146
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
Derived failure modes
-
Device software or design
Software defect