Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 16 recalls
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Screw may loosen or fallout of Hemodialysis system
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Norm…