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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens AXIOM Artis zeego

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 Class 2 Recall
Siemens AXIOM Artis zeego
see related information
Date Posted August 09, 2013
Recall Status1 Open
Recall Number Z-1945-2013
Recall Event ID 65721
Premarket Notification
510(K) Number
K090745 
Product Classification System, X-Ray, Angiographic - Product Code IZI
Product Siemens AXIOM Artis zeego x-ray, angiographic system
Code Information Model number 10280959
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Siemens Customer Service
888-826-9702
Manufacturer Reason
for Recall
Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm, Siemens, sent an "Important safety notice" by letter on May 13, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately notify the service department to clarify what further measures need to be taken, if after carrying out the regular brake test, the system can only be moved at a reduced speed. If this device has been sold and is therefore no longer in your possession, send this safety notice to the new owner and provide the new owner to Siemens. Update instruction AX012/13/S was issued, and a software update will be released as AX006/13/S and AX007/13/S which will modify the system software so that it will not be possible for information to be overlaid. If you have any questions call +49 (9191) 18 0.
Quantity in Commerce 132
Distribution Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI.
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 = IZI and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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