Transonic Systems Inc recalls Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.

Recall date

July 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2727-2015

FDA classification

Class II

Brand / firm

Transonic Systems Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.