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Recall Observatory FDA recall evidence

Device product

Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.

Z-2722-2015

July 27, 2015

Class II

Product summary

Firm
Transonic Systems Inc
Event
Event 71907
Status
Terminated
Classification
Class II
Quantity
Domestic: 1 unit
Official record key
device-enforcement:Z-2722-2015

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 Number: HQC6FMV2239

Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software defect