• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
CR 10X Image Plate 35CM X 43CM
see related information
Date Posted March 19, 2013
Recall Status1 Terminated on June 06, 2013
Recall Number Z-0970-2013
Recall Event ID 64529
Premarket Notification
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/
Manufacturer
AGFA Corp.
10 S Academy St
Greenville, South Carolina 29601-2632
For Additional Information Contact Debbie Huff
864-421-1754
Manufacturer Reason
for Recall
The cassettes were shipped with the wrong IP (image plate) size bar code.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 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 = MQB and Original Applicant = PRACTICAL COMPLIANCE, LLC
-
-