Company: Transonic Systems Inc
Date of Enforcement Report 9/9/2015
Transonic Flow Probes. Product Usage: to measure flow intra-operatively
Reacll number 2720-2729.
Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69.
Transonic Systems Inc, ithaca, NY on 7/27/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally.