Recall Z-1435-2011 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. The suite is comprised of modular software that runs on industry standard personal computers and servers, utilizing Windows 2000/2003/XP operating systems. Image data storage
| Date | Feb 25, 2011 (initiated Apr 15, 2009) |
| Status | Terminated |
| Reason | User could modify a measurement's units and that change would not be reflected in echocardiography formulas used within the Adult echocardiography RM. |
| Root cause | Other |
| Action | The firm, Agfa Healthcare, sent individual letters dating from April 15, 2009 to August 26, 2009, to the customers. The letters described the product, problem and actions to be taken. Agfa provided the affected customer with a complete list of their impacted patients and the measurements. Agfa also scheduled unit corrections with their customers and received acknowledgement of the letters at the time of scheduling the unit corrections. Service Bulletin DIS026.09E was issued January 2009 to inform users that Agfa will no longer allow customers to request unit changes for measurements that hav |
| Quantity | 6 devices |
| Distribution | Nationwide distribution: USA including states of: IL, MT, NY, OR and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |