Home / Recalls / Transonic Systems Inc / Z-2728-2015

Z-2728-2015 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: 15 units, Foreign: 2 units

Product Description

Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- 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: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511, HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516, HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520

Other recalls by Transonic Systems Inc

  • Z-1776-2018 Class II — Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-4 (February 15, 2018)
  • Z-2727-2015 Class II — Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measu (July 27, 2015)
  • Z-2724-2015 Class II — Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to meas (July 27, 2015)
  • Z-2723-2015 Class II — Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measu (July 27, 2015)
  • Z-2720-2015 Class II — Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measur (July 27, 2015)
  • Z-2725-2015 Class II — Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measur (July 27, 2015)
  • Z-2726-2015 Class II — Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measu (July 27, 2015)
  • Z-2721-2015 Class II — Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to meas (July 27, 2015)
  • Z-2729-2015 Class II — Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to mea (July 27, 2015)
  • Z-2722-2015 Class II — Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to mea (July 27, 2015)