Recall Z-0945-2009 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiving and communications system intended to be used as a networked cardiovascular information management system. The IMPAX Centric Polling Procedure provides a mechanism to ensure that patient demograp
| Date | Feb 3, 2009 (initiated Dec 24, 2008) |
| Status | Terminated |
| Reason | Polling procedure may fail when multiple merge/split is carried out. |
| Root cause | Software design |
| Action | All sites potentially affected by this product were notified of the issue directly via telephone. Each site was directed to observe a ten minute polling window as an interim mitigation until the normal mitigation by software Service Update is performed at the site by Agfa Support. An Urgent Safety Notice was sent via FED-EX on/about 12/24/2008 to all sites. The letter describes the potential issue and both interim and formal mitigation. Acknowledgment, via FAX-Back, that the information was received and understood was requested from the sites. |
| Quantity | 5 units |
| Distribution | Nationwide Distribution --- including states of FL, IL, OR, SC, and SD. |
| FDA record | Open on fda.gov |