Recall Z-1295-2015 ยท MQS System, Hemodialysis, Access Recirculation Monitoring
Transonic Systems Inc
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.
| Date | Mar 18, 2015 (initiated Feb 17, 2015) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Process control |
| Action | Transonic sent a Medical Device Recall Letters and Response Forms dated February 17, 2015 to the users via e-mail and fax. The recall is being conducted to the user level. The letter identified the affected product, problem and actions to be taken. For questions call 607-257-5300 ext. 326. |
| Quantity | Domestic: 21 units, Foreign: 10 units |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960817 | HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) Transonic Systems, Inc., Feb 11, 1997 |