Date Initiated by Firm |
January 27, 2011 |
Date Posted |
February 24, 2011 |
Recall Status1 |
Terminated 3 on March 29, 2011 |
Recall Number |
Z-1434-2011 |
Recall Event ID |
57821 |
510(K)Number |
K050228
|
Product Classification |
System, image processing, radiological - Product Code LLZ
|
Product |
Cardiovascular Review Station
The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting. |
Code Information |
Software Versions 2.12.05 - 2.14.03.SU1 |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
|
For Additional Information Contact |
Jeffery A. Jedlicka 864-421-1815
|
Manufacturer Reason for Recall |
Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports.
|
FDA Determined Cause 2 |
Other |
Action |
The firm, AGFA Healthcare, sent a "Safety Notice" dated January 27, 2011 to all customers. The notice described the product, problem and action to be taken by firm and customer. AGFA informed the customers that a software upgrade was made between December 2008 and February 2010 and instructed the customers to distribute this information to all individuals within their facility and to complete and return the attached URGENT SAFETY NOTICE FEEDBACK FORM via fax to 864-421-1664 or email to debbie.norris@agfa.com.
Note: Service Bulletin DD+DIS100.09E, was issued March 2009 and an upgrade from Software Versions 2.12.05 through 2.14.03.SU1 to Software Version CRS 2.14.03.SU2 was required for the impacted sites. Most identified consignees/customers required the software upgrade, but some consignees/customers had already been upgraded prior to the event and did not require additional upgrades.
If you have any questions about this matter, please contact the Post Market/QARA North America via email at debbie.norris@agfa.com or call at 864-421-1754. |
Quantity in Commerce |
107 |
Distribution |
Worldwide distribution: USA and country of: 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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