Recall Z-1295-2015— Transonic Systems Inc
Class II · Terminated
Class II FDA medical device recall by Transonic Systems Inc, initiated 2015-02-17, terminated 2016-05-31. It names one FDA 510(k) clearance: K960817. Product: 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: 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)..
- Recalling firm
- Transonic Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-17
- Terminated
- 2016-05-31
- Firm location
- Ithaca, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.