CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)
This recall has been terminated (originally issued January 6, 2006).
- Company
- Agfa Corp.
- Recall Initiated
- November 18, 2005
- Posted
- January 6, 2006
- Terminated
- June 30, 2009
- Recall Number
- Z-0353-06
- Quantity
- 2630 units
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.
Distribution
Nationwide
Lot / Code Info
Software versions: ADC QS 2.0, CR QS 3.O.207, CR QS 3.O.210, CR QS 3.0.210SU1, CRQS 3.0.229, Centricity CR Online Processing software 2.x.
Root Cause
Other
Action Taken
Consignees will be notified by letter on/about December 1, 2005 and offered upgraded software.
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