AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS),
FDA device recall Z-2252-2012 · posted 2012-08-22 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- 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).
- 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
- Root cause
- Process design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 535
- Distribution
- USA Nationwide, Virgin Islands and Canada
- Date initiated
- 2012-08-09
- Date posted
- 2012-08-22
- Date terminated
- 2015-12-08
- Location
- Greenville, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGFA HEARTLAB CARDIOVASCULAR (K050228) | Heartlab, Inc. | 2005-02-18 |