Recall Z-2184-2012 ยท LLZ System, Image Processing, Radiological
AGFA Corp.
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
| Date | Aug 10, 2012 (initiated Jul 27, 2012) |
| Status | Terminated |
| Reason | Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report. |
| Root cause | Software change control |
| Action | AGFA Healthcare sent an URGENT FIELD SAFETY NOTICE dated July 27, 2012, to all affected customers. The letter described the safety alert and mitigation. Customer were asked to complete the Acknowledgment form and fax back to 864-421-1664 that the information was received and understood. For questions customers were instructed tol call 401-604-2180. For questions regarding this recall call 864-421-1754. |
| Quantity | 280 |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |