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.
FDA Recall Z-1295-2015 · Posted 2015-03-18
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Recalling FirmTransonic Systems Inc
Recall StatusTerminated
Product CodeMQS
Date Initiated2015-02-17
Date Terminated2016-05-31
Product QuantityDomestic: 21 units, Foreign: 10 units
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).
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of: Australia, Canada, and South Korea
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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