device · product 1 of 10
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
- Recall number
- Z-2720-2015
- Initiated
- July 27, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Transonic Systems Inc
- Quantity
- Domestic: 4 units
App-derived interpretation
Software defect
Official device-enrichment evidence · Sourced
Software Manufacturing/Software Deployment
Inspect official wording and provenance
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.
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.