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Transonic Systems Inc recalls Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
Recalled September 9, 2015 · FDA recall Z-2728-2015 · Transonic Systems
Hazard
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. · FDA Class II
Units
Domestic: 15 units, Foreign: 2 units
Sold at
Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
Description
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.
Product
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
Manufacturer(s)
Transonic Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →