Recall Z-2652-2017 ยท LLZ System, Image Processing, Radiological
AGFA Healthcare Corp.
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats
| Date | Dec 22, 2016 |
| Status | Terminated |
| Reason | A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm. |
| Root cause | Software design |
| Action | AGFA Healthcare sent an Urgent Field Safety Notice dated December 22, 2016, to all affected consignees. The notice included an acknowledgement fax-back or email indicating that the information was received and understood. The notice informed the consignees of the problem and indicated that they would be contacted by Agfa Service to check the problem and to correct the NIV reporting clinical content. Customers with questions were instructed to call 1-401-330-7433. For questions regarding this recall call 864-421-1984. |
| Quantity | 10 |
| Distribution | Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050228 | AGFA HEARTLAB CARDIOVASCULAR Heartlab, Inc., Feb 18, 2005 |