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U.S. Department of Health and Human Services

Class 2 Device Recall CR 10X Image Plate 35CM X 43CM

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  Class 2 Device Recall CR 10X Image Plate 35CM X 43CM see related information
Date Initiated by Firm February 07, 2013
Date Posted March 19, 2013
Recall Status1 Terminated 3 on June 06, 2013
Recall Number Z-0970-2013
Recall Event ID 64529
510(K)Number K121948  
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
Product CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
Code Information Batch No. A2KQMW
Recalling Firm/
AGFA Corp.
10 S Academy St
Greenville SC 29601-2632
For Additional Information Contact Debbie Huff
Manufacturer Reason
for Recall
The cassettes were shipped with the wrong IP (image plate) size bar code.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On February 7, 2013, AGFA called dealers involved to alert them of the safety issue. Also, an 'URGENT FIELD SAFETY NOTICE" letter dated February 26, 2013 was sent to the customers. The letter described the affected product, problem and actions to be taken. Customers were requested to check their inventories for the affected product and block any identified product within their inventory. Customers were instructed to complete the attached Feedback form and return via FAX or email. For questions call 877-777-2432 Prompt 5.
Quantity in Commerce 17
Distribution USA Nationwide Distribution including the states of: AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
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 N.V.