Recall Z-0366-2010 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
AGFA IMPAX HeartStation ECG Management System.
| Date | Nov 18, 2009 (initiated May 7, 2009) |
| Status | Terminated |
| Reason | HeartStation does not refresh content changes to the PDF reports that are printed emailed or faxed from the Index page. This may lead to a discrepancy in patient demographics between what is displayed in the HeartStation Client interface and the report delivered to the consumer. Questions are being directed to the local Agfa representative; the contact information was included in the letter. |
| Root cause | Other |
| Action | An Urgent Safety Notice was sent via FED-EX to all the sites with the affected units (a total of 6) on May 7, 2009. The three foreign accounts were notified by letter on May 14, 2009. The letter describes the potential issue and mitigation. Acknowledgment via FAX-Back that the information was received and understood was requested from the sites. Customers who use the print, email, fax functionality of this product were verbally notified of the defect and they have been advised of a workaround. In the notice letter, Agfa HealthCare is also providing customers with the recommended workaround. Th |
| Quantity | 9 units |
| Distribution | CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050858 | ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM Heartlab, Inc., Jun 29, 2005 |