AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
This recall has been terminated (originally issued August 22, 2012).
- 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
- Official Source
- View on FDA website ↗
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