FDA-Device2015-09-09Class II
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
Transonic Systems Inc
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.
Sold states
Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.
Affected count
Domestic: 2 units
Manufactured in
34 Dutch Mill Rd, N/A, Ithaca, NY, United States
Products
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2729-2015Don't want to check this manually?
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