Device product
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
Z-2720-2015
Product summary
- Event
- Event 71907
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 4 units
- Official record key
device-enforcement:Z-2720-2015
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: HQC2FMC1801, HQC2FMC 1802, HQC2FMC1805, HQC2FMC1806
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