IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
This recall has been terminated (originally issued March 16, 2011).
- Company
- Agfa Corp.
- Recall Initiated
- February 10, 2011
- Posted
- March 16, 2011
- Terminated
- September 15, 2011
- Recall Number
- Z-1676-2011
- Quantity
- One
- Firm Location
- Greenville, SC
- Official Source
- View on FDA website ↗
Reason for Recall
A discrepancy in the validation testing which resulted in the product not performing as intended.
Distribution
TX
Lot / Code Info
Model Number CV7.8 Catalog Number CM 60+ 00091915, Software Version CRS Remote_7.8_HL
Root Cause
Device Design
Action Taken
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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