Sep

2015

Cl II Transonic Flow Probes

Company: Transonic Systems Inc
Date of Enforcement Report 9/9/2015
Class lI:

PRODUCT

Transonic Flow Probes. Product Usage: to measure flow intra-operatively
Reacll number 2720-2729.

REASON
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.

RECALLING FIRM/MANUFACTURER
Transonic Systems Inc, ithaca, NY on 7/27/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
Nationwide and Internationally.

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II Transonic Flow Probes

Amy Sellers

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