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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Iconos R200

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 Class 2 Recall
Axiom Iconos R200
see related information
Date Posted March 27, 2010
Recall Status1 Terminated on August 11, 2010
Recall Number Z-1213-2010
Recall Event ID 54616
Premarket Notification
510(K) Number
K992660 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Axiom Iconos R200 X-Ray
Code Information Model numbers 10093961, 5902767, 5902775, 5902783, 5902791, 5904086, 7152460, and 7152478
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Technical Support
888-826-9702
Manufacturer Reason
for Recall
table can tilt/move when it is not intended
FDA Determined
Cause 2
DESIGN: Software Design
Action The recalling firm has issued a letter to affected customers and will send technicians to apply the fix to each defective device.
Quantity in Commerce 169 units
Distribution Nationwide Distribution.
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 = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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