Recall Z-1069-2013 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.
| Date | Apr 8, 2013 (initiated Mar 15, 2013) |
| Status | Terminated |
| Reason | Software design error in IMPAX CV 7.8 SU3 |
| Root cause | Software design |
| Action | AGFA Healthcare sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to distribute this information within your facility to all individuals who need to be aware of this. Please fax back to (864) 421-1664 that the information was received and understood was requested from the customers. If you have any questions about this matter please contact your local AGFA Healthcare organization, or call (864) 421-1754. |
| Quantity | 2 |
| Distribution | Distribute in the state of FL and KY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |