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
This recall has been terminated (originally issued December 22, 2016).
- Company
- Agfa Healthcare Corp.
- Recall Initiated
- December 22, 2016
- Terminated
- August 27, 2021
- Recall Number
- Z-2652-2017
- Quantity
- 10
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI
Lot / Code Info
Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6
Root Cause
Software design
Action Taken
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.