FDA Device

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

Hazard

Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

What You Should Do

Remedy

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.

Products

IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Brand
AGFA Corp.
UPC
Model # L9M2100 - All Software versions of IMPAX CV Reporting

Units Affected

280