Home / Recalls / Transonic Systems Inc / Z-1295-2015

Z-1295-2015 Class II Terminated

Recalled by Transonic Systems Inc — Ithaca, NY

Recall Details

Product Type
Devices
Report Date
March 25, 2015
Initiation Date
February 17, 2015
Termination Date
May 31, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Domestic: 21 units, Foreign: 10 units

Product Description

Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.

Reason for Recall

Customer unable to obtain measurements due to the device seeing no flow or irrelevant flow condition during dialysis procedures. The user saw a zero or a very low flow value displayed on HD03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).

Distribution Pattern

Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea

Code Information

Serial Numbers HD03A60004; HD03A81167; HD03A81225; HD03A81237; HD03A91338; HD03A91394; HD03A91406; HD03B01461; HD03B21782; HD03B21803; HD03A60020; HD03A71082; HD03A81207; HD03A91255; HD03A91316; HD03Bl1679; HD03B11684; HD03B11705; HD03B21812; HD03B31971; HD03A81240; HD03A71086; HD03B01459; HD03B01594; HD03B11667; HD03B42175; HD03B42160; HD03B42161; HD03A91258; HD03A70046; HD03B31901

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-2722-2015 Class II — Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to mea (July 27, 2015)
  • Z-2726-2015 Class II — Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measu (July 27, 2015)
  • Z-2728-2015 Class II — Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure (July 27, 2015)
  • Z-2721-2015 Class II — Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to meas (July 27, 2015)