FDA Medical Device Recalls (openFDA)
AGFA Corp.: AGFA IMPAX HeartStation ECG Management System.
- Recall number
- Z-0366-2010
- Recalling firm
- AGFA Corp.
- Product
- AGFA IMPAX HeartStation ECG Management System.
- Status
- Terminated
- Initiated
- 2009-05-07
- Posted
- 2009-11-18
- Terminated
- 2010-07-27
- 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. 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.
- Quantity
- 9 units
- Distribution
- CA, KY, MA, NY, OH, SC, Belgium, Italy and Singapore
- Lot, serial or model codes
- Model number HeartStation 1.1 60+00091179 to 60+0091186; HeartStation Core Server 60+00091211; CV HeartStation EZKT7000, L9NBN000, EZKC000, L9NAL000, EZKWE000 and L9M9G000.
- 510(k) numbers
- ["K050858"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3001236302
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28