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U.S. Department of Health and Human Services

Class 2 Device Recall CRS Remote

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 Class 2 Recall
CRS Remote
see related information
Date Posted March 16, 2011
Recall Status1 Terminated on September 15, 2011
Recall Number Z-1676-2011
Recall Event ID 57932
Premarket Notification
510(K) Number
K050228 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
Code Information Model Number CV7.8 Catalog Number CM 60+ 00091915, Software Version CRS Remote_7.8_HL
Recalling Firm/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Jeffery A. Jedlicka
864-421-1815
Manufacturer Reason
for Recall
A discrepancy in the validation testing which resulted in the product not performing as intended.
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce One
Distribution TX
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
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