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COBAS 8000 CORE UNIT (2017-07-20)
- Starting date:
- July 20, 2017
- Posting date:
- November 10, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-65050
Affected products
COBAS 8000 CORE UNIT
Reason
A software limitation which in rare cases, could reset the system configuration of the cobas 8000 control unit software (versions 05-02, 06-02 and 06-03) to default settings.
Affected products
COBAS 8000 CORE UNIT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5641446001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY