MQSClass IILife-sustaining

System, Hemodialysis, Access Recirculation Monitoring

Gastroenterology, Urology · 21 CFR 876.5820

MDR events271All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances18All time

Recent MDR events

271 adverse event reports on file

Event type breakdown

Malfunction229

Other23

Death12

Injury6

Unspecified1

Most-reported manufacturers

Gambro Lundia Ab, Monitor Division95 Gambro Lundia Ab32 Gambro Lundia Ab, Monitor Div.28 Gambro Renal Products, Inc.27 Unspecified15 Gambro Lundia Ab, Monitor Div10 Gambro Lundia Ab, Monitors10 Gambro Renal Products, Inc8

Recalls

1 recall events for this product code

Transonic Systems Inc
TerminatedMar 18, 2015
Transonic Hemodialysis Monitor, Model HD03 --
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).
Z-1295-2015 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

18 clearances for this product code