Device product
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
Z-2725-2015
Product summary
- Event
- Event 71907
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 6 units
- Official record key
device-enforcement:Z-2725-2015
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: HQC3MP4665, HQC3MP4666, HQC3MP4667, HQC3MP4668, HQC3MP4669, HQC3MP4670
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