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Health product recall

Dialog+ Dialysis machiines and Option Adimea with Software 8.2A (2016-10-11)

Starting date:
October 11, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-60720

Affected Products 

A. Dialog+ Dialysis machines with Software 8.2A^

B. Dialog+ Dialysis machines with Software 8.2A

C. Option Adimea with Sotfware 8.2A

Reason

Error in the software affecting the timer/stop watch function.  Under certain conditions the warning is reset by the machine without user interaction.  The reminder function may fail.

Affected products

A. Dialog+ Dialysis machines with Software 8.2A^

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

710500XV

Companies
Manufacturer

B. Braun Avitum Ag

Schwarzenberger Weg 73-79

Melsungen

34212

GERMANY



B. Dialog+ Dialysis machines with Software 8.2A

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

710507EV

Companies
Manufacturer

B. Braun Avitum Ag

Schwarzenberger Weg 73-79

Melsungen

34212

GERMANY



C. Option Adimea with Sotfware 8.2A

Lot or serial number

More than 10 numbers, contact manufacturer.

Companies
Manufacturer

B. Braun Avitum Ag

Schwarzenberger Weg 73-79

Melsungen

34212

GERMANY