IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
This recall has been terminated (originally issued October 12, 2006).
- Company
- Agfa Corp.
- Recall Initiated
- August 8, 2006
- Posted
- October 12, 2006
- Terminated
- February 20, 2007
- Recall Number
- Z-0033-2007
- Quantity
- 20 Impax 5.2 Mammo licenses were issued domestically.
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
Failed CAD displayed as 'No Findings'
Distribution
Nationwide.
Lot / Code Info
Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433, Diagnostic Workstation/Impax 5.2/with CAD Capability/CRT: 60+00024432 and Clinical Review Station/Impax 5.2/with CAD Capability/Flat Panel: 60+00024438. Software version Impax 5.2.2 sites using CAD.
Root Cause
Other
Action Taken
Consignees were notified by letter on/about 08/08/2006.
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