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Terminated

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

FDA Recall Z-2727-2015 · Posted 2015-09-03

Recalling FirmTransonic Systems Inc
Recall StatusTerminated
Product CodeDPW
Date Initiated2015-07-27
Date Terminated2016-07-18
Product QuantityDomestic: 35 units, Foreign: 12 units

Reason for Recall

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.

Firm Action

Transonic sent an Urgent Medical Device Recall letters and Response Forms dated July 27, 2015 to customers via Certified Mail, email and/or fax. The letter identified the affected product, problem and actions to be taken. Customers are instructed to contact Transonic Systems' Customer Service at 1-800-353-3569 or 1-607-257-5300 to arrange for replacement (repair/exchange) immediately.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K872048TRANSONIC FLOWMETERTransonic Systems, Inc. · 1988-06-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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