Device product
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
Z-2726-2015
Product summary
- Event
- Event 71907
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 8 units, foreign: 11 units
- Official record key
device-enforcement:Z-2726-2015
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: HQD2FMC2797, HQD2FMC2873, HQD2FMC2874, HQD2FMC2875, HQD2FMC2876, HQD2FMC2877, HQD2FMC2878, HQD2FMC2879, HQD2FMC2880, HQD2FMC2881, HQD2FMC2882, HQD2FMC2883, HQD2FMC2884, HQD2FMC2885, HQD2FMC2886, HQD2FMC2888, HQD2FMC2889, HQD2FMC2890, HQD2FMC2908
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