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U.S. Department of Health and Human Services

Class 2 Device Recall AGFA Computed Radiography system with NX2.X Workstations

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  Class 2 Device Recall AGFA Computed Radiography system with NX2.X Workstations see related information
Date Initiated by Firm June 30, 2010
Date Posted July 26, 2010
Recall Status1 Terminated 3 on April 28, 2011
Recall Number Z-2100-2010
Recall Event ID 56158
510(K)Number K071162  
Product Classification solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack with LCD Arm

Agfa's Computed Radiography Systems with NX2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
Code Information LU8QJ000
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		 Monitor fell from the mounting bracket used to support the monitor.
FDA Determined
Cause 2		 Other
Action The firm, AGFA Healthcare sent an 'URGENT SAFETY NOTICE" dated June 30, 2010, via FED-EX to customers. The letter describes product, problem and actions to be taken by the firm and customers. AGFA will provide a safety check to the customers facility, have a service representative visit , in the near future, their site to inspect the monitor/s and attach a warning label on each monitor checked for preventative action. The customers are ask to distribute the information within their facility to all individuals who need to be aware, to complete the attached URGENT SAFETY NOTICE FEEDBACK FORM as soon as possible and return via fax at 864-421-1664. If you have any questions about this matter, please feel free to contact me via email at Debbie.norris@agfa.com or call me at 864-421-1754.
Quantity in Commerce 805 units
Distribution Worldwide distribution: USA and countries of Puerto Rico and Canada.
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 = MQB and Original Applicant = AGFA HEALTHCARE CORP.
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