Date Initiated by Firm |
February 10, 2011 |
Date Posted |
March 16, 2011 |
Recall Status1 |
Terminated 3 on September 15, 2011 |
Recall Number |
Z-1676-2011 |
Recall Event ID |
57932 |
510(K)Number |
K050228
|
Product Classification |
cardiovascular information system. - 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 SC 29601-2632
|
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 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = HEARTLAB, INC.
|