Transonic Systems Inc Recall: Transonic Hemodialysis Monitor, Model HD03 -- Product Usage:
Transonic Systems Inc Recall: Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Transonic Systems Inc; Product: Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by traine
| Recalling firm | Transonic Systems Inc |
|---|---|
| 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 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). |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea |
| Recall initiated | 20150217 |
| Recall number | Z-1295-2015 |
| Category | device |
| State | NY |
| Country | United States |
$29/mo
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