FDA Device

IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8

Hazard

A discrepancy in the validation testing which resulted in the product not performing as intended.

What You Should Do

Remedy

AGFA sent an "URGENT SAFETY NOTICE" letter dated 2/10/11 via FED-EX to the customer. The letter included an acknowledgment which was to be FAX-Back indicating that the information was received and understood. Agfa has discussed with the customer how the de-installation of their CRS Remote product - Software Version 7.8_HL would be performed.

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Products

IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
Brand
AGFA Corp.
UPC
Model Number CV7.8 Catalog Number CM 60+ 00091915, Software Version CRS Remote_7.8_HL

Units Affected

One

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