Transonic Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-1295-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 17, 2015

Date Posted: March 25, 2015

Recall Number: Z-1295-2015

Event ID: 70647

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).

Status: Terminated

Product Quantity: Domestic: 21 units, Foreign: 10 units

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated