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Class 2 Device Recall CR 10X Image Plate 35CM X 43CM |
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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
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Product Classification |
Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
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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.
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Code Information |
Batch No. A2KQMW |
Recalling Firm/ Manufacturer |
AGFA Corp. 10 S Academy St Greenville SC 29601-2632
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For Additional Information Contact |
Debbie Huff 864-421-1754
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Manufacturer Reason for Recall |
The cassettes were shipped with the wrong IP (image plate) size bar code.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MQB and Original Applicant = AGFA HEALTHCARE N.V.
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