Device product
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Z-2184-2012
Product summary
- Firm
- AGFA Corp.
- Event
- Event 62646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 280
- Official record key
device-enforcement:Z-2184-2012
Official wording
Reason: Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.
Code information: Model # L9M2100 - All Software versions of IMPAX CV Reporting
Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada
Derived failure modes
-
Unknown
Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.