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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS Pheno, Fluoroscopic XRay system

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 Class 2 Device Recall ARTIS Pheno, Fluoroscopic XRay systemsee related information
Date Initiated by FirmMay 30, 2018
Create DateJuly 20, 2018
Recall Status1 Terminated 3 on February 14, 2020
Recall NumberZ-2524-2018
Recall Event ID 80417
510(K)NumberK163286 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Code Information 164033,  164071,  164034,  164095,  164057,  164054,  164055,  164080,  164072,  164088,  164048,  164094,  164068,  164019,  164013,  164073,  164025,  164026,  164027,  164060,  164083,  164021,  164066,  164075,  164074,  164084,  164086,  164098,  164028,  164053,  164063,  164064,  164024,  164049,  164018,  164022,  164061,  164100,  164097,  164011
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactMeredith Adams
610-448-6461
Manufacturer Reason
for Recall		During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
FDA Determined
Cause 2		Device Design
ActionAn Urgent Medical Device Correction notification was distributed to customers on 5/30/18. The notification provided the following information to customers: Siemens will correct the error by inspecting all affected ARTIS Pheno systems. As an immediate measure to prevent movement stops during a C-arm rotation followed by a C-arm drop, the maximum rotation speeds will be reduced. This correction limits the maximum manual LAO/RAO rotation from 25/sec to 20/sec and Cran/Caud rotation from 20/sec to 10/sec. All other system parameters as well as 3D acquisition and Perivision/Peristepping remain unaffected. You may continue to use the ARTIS Pheno system while awaiting implementation of the corrective action. Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX004/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. Additionally, Siemens is developing a solution to restore the system back to the original settings. This solution will be distributed to all affected customers upon completion.
Quantity in Commerce40 in the United States
DistributionThe devices were distributed to the following US states: AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, ME, NJ, NY, OH, TN, TX, UT, and VA.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = OWB
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