AGFA IMPAX HeartStation ECG Management System.
- Company
- Agfa Corp.
- Recall Initiated
- May 7, 2009
- Posted
- November 18, 2009
- Terminated
- July 27, 2010
- Recall Number
- Z-0366-2010
- Quantity
- 9 units
- Firm Location
- Greenville, SC
Reason for Recall
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.
Distribution
CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
Lot / Code Info
Model number HeartStation 1.1 60+00091179 to 60+0091186; HeartStation Core Server 60+00091211; CV HeartStation EZKT7000, L9NBN000, EZKC000, L9NAL000, EZKWE000 and L9M9G000.
Root Cause
Other
Action Taken
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. The workaround is to only print from the Viewer screen or to print the ECG once confirmed. The Viewer screen, however, does not allow the user to print batches of reports as does the Index screen. Questions about this matter are being directed to the local Agfa HealthCare representative.