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U.S. Department of Health and Human Services

Class 2 Device Recall AXIOM Artis and AXIOM Artis zee modular angiographic systems

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 Class 2 Recall
AXIOM Artis and AXIOM Artis zee modular angiographic systems
see related information
Date Posted January 27, 2012
Recall Status1 Terminated on January 31, 2014
Recall Number Z-0927-2012
Recall Event ID 60989
Premarket Notification
510(K) Number
K052202 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems
Code Information Model numbers 5904433, 5904441, 5904649, 5904656, 5904466, 7007755, 7728350, 7412807, 7727717, 7728392, 7413078, 7555373, 7555365, 7555357, 7008605, 5917054, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Anastasia Mason
610-219-4834
Manufacturer Reason
for Recall
There is a potential misalignment in the connection of the remote foot switch and the stationary unit. This potential malfunction may occur if either the wireless foot switch or the stationary unit is equipped with improper firmware installed in the bluetooth interface performing the communication between foot switch and system. This is not a general issue but sporadic as a vendor unsystematical
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action Siemens sent an Urgent Field Safety Notice letter on January 16, 2016, to all affected customers The letter identified the product, problem, potential risk, and actions to be taken. Customers were instructed to immediately pass this information to all those who need to be aware and instruct personnel accordingly. Siemens ask that if the device/equipment is no longer in the customers possession to forward this safety notice to the new owner of the device/equipment.
Quantity in Commerce 45
Distribution Nationwide Distribution (USA) including the states of: CA, CT, FL, GA, HI, IL, IN, KY, ME, MD, MI, MS, MO, NH, NJ, NY, NC, OH, OR, TN, TX, UT, VA, WI and Puerto Rico.
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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