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Recall Observatory FDA recall evidence

Device product

Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.

Z-2721-2015

July 27, 2015

Class II

Product summary

Firm
Transonic Systems Inc
Event
Event 71907
Status
Terminated
Classification
Class II
Quantity
Domestic: 36 units
Official record key
device-enforcement:Z-2721-2015

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: HQC3FMC2501, HQC3FMC2502, HQC3FMC2503, HQC3FMC2504, HQC3FMC2505, HQC3FMC2506, HQC3FMC2507, HQC3FMC2508, HQC3FMC2509, HQC3FMC2510, HQC3FMC2511, HQC3FMC2512, HQC3FMC2513, HQC3FMC2514, HQC3FMC2515, HQC3FMC2516, HQC3FMC2517, HQC3FMC2518, HQC3FMC2519, HQC3FMC2520, HQC3FMC2521, HQC3FMC2522, HQC3FMC2523, HQC3FMC2524, HQC3FMC2525, HQC3FMC2526, HQC3FMC2527, HQC3FMC2528, HQC3FMC2529, HQC3FMC2530, HQC3FMC2531, HQC3FMC2532, HQC3FMC2533, HQC3FMC2534, HQC3FMC2535, HQC3FMC2636

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