Recall Z-1434-2011 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
Cardiovascular Review Station The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting.
| Date | Feb 24, 2011 (initiated Jan 27, 2011) |
| Status | Terminated |
| Reason | Echocardiography volume measurements performed within CRS were not reflected correctly in associated Results Management (RM) reports. |
| Root cause | 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 S |
| Quantity | 107 |
| Distribution | Worldwide distribution: USA and country of: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |