Date Initiated by Firm |
August 09, 2012 |
Date Posted |
August 22, 2012 |
Recall Status1 |
Terminated 3 on December 08, 2015 |
Recall Number |
Z-2252-2012 |
Recall Event ID |
62796 |
510(K)Number |
k050228
|
Product Classification |
Medical Image Storage Device - Product Code LLZ
|
Product |
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device |
Code Information |
All software versions of DICOMstore in combination with Media Purge Daemon (MPD) or Cardiovascular Purge Services (CPS). |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
|
For Additional Information Contact |
Debbie Huff 864-421-1754
|
Manufacturer 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).
|
FDA Determined Cause 2 |
Process design |
Action |
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 |
Quantity in Commerce |
535 |
Distribution |
USA Nationwide, Virgin Islands and Canada |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
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