Z-2720-2015 Class II Terminated

Recalled by Transonic Systems Inc — Ithaca, NY

Recall Details

Product Type
Devices
Report Date
September 9, 2015
Initiation Date
July 27, 2015
Termination Date
July 18, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Domestic: 4 units

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.

Distribution Pattern

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

Code Information

Serial Numbers: HQC2FMC1801, HQC2FMC 1802, HQC2FMC1805, HQC2FMC1806