AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
- Company
- Agfa Corp.
- Recall Initiated
- August 9, 2012
- Posted
- August 22, 2012
- Terminated
- December 8, 2015
- Recall Number
- Z-2252-2012
- Quantity
- 535
- Firm Location
- Greenville, SC
Reason for Recall
Loss of patient data can occur under certain circumstances due to misconfiguration of DICOMstore configured with Agfa's Medical Image Storage Devices - Media Purge Daemon (MPD) and Cardiovascular Purge Service (CPS).
Distribution
USA Nationwide, Virgin Islands and Canada
Lot / Code Info
All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS).
Root Cause
Process design
Action Taken
On 8/9/2012 AGFA Healthcare issued an "URGENT FIELD SAFETY NOTICE" letter to consignees. This letter describes the problem and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood was also required from the consignees
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