ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
This recall has been terminated (originally issued August 3, 2006).
- Company
- Radiometer America Inc
- Recall Initiated
- October 31, 2005
- Posted
- August 3, 2006
- Terminated
- February 24, 2012
- Recall Number
- Z-1325-06
- Quantity
- 36
- Firm Location
- Westlake, OH
- Official Source
- View on FDA website ↗
Reason for Recall
ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched.
Distribution
Worldwide, including USA and Canada.
Lot / Code Info
All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx
Root Cause
Other
Action Taken
The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.
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