Recall Z-2720-2015— Transonic Systems Inc

Name: FDA recall Z-2720-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-27

Class II · Terminated

Class II FDA medical device recall by Transonic Systems Inc, initiated 2015-07-27, terminated 2016-07-18. It names one FDA 510(k) clearance: K872048. Product: Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.. Reason: 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..

Recalling firm: Transonic Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Terminated: 2016-07-18
Firm location: Ithaca, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K872048 — TRANSONIC FLOWMETERTransonic Systems, Inc.·cleared 1988-06-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.