Recall Z-0211-2012 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2 The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting.
| Date | Nov 18, 2011 (initiated Jun 6, 2011) |
| Status | Terminated |
| Reason | Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable. |
| Root cause | Software design |
| Action | AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated May 27, 2011, via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to carry out a merge post finalization of an RM reports. If it is necessary to modify a finalized report, AGFA recommends that they make the modification through one of the following actions: Amend the report through the RM interface, or Call AGFA Service to change the status of the report to "preliminary" and then proceed with the finalization of the re |
| Quantity | 323 |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |