Z-1295-2015 Class II Terminated
FDA device recall Z-1295-2015 was initiated by Transonic Systems Inc on February 17, 2015 and is designated Class II. 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 … The recall status is terminated (terminated May 31, 2016). Affected quantity: Domestic: 21 units, Foreign: 10 units.
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