Recall Z-2252-2012— AGFA Corp.
Class II · Terminated
Class II FDA medical device recall by AGFA Corp., initiated 2012-08-09, terminated 2015-12-08. It names one FDA 510(k) clearance: K050228. Product: AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device. Reason: 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)..
- Recalling firm
- AGFA Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-09
- Terminated
- 2015-12-08
- Firm location
- Greenville, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.