IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
This recall has been terminated (originally issued August 10, 2012).
- Company
- Agfa Corp.
- Recall Initiated
- July 27, 2012
- Posted
- August 10, 2012
- Terminated
- January 13, 2015
- Recall Number
- Z-2184-2012
- Quantity
- 280
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Distribution
Worldwide Distribution - USA (nationwide) and Canada
Lot / Code Info
Model # L9M2100 - All Software versions of IMPAX CV Reporting
Root Cause
Software change control
Action Taken
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.