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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS PhenoInterventional Fluoroscopic XRay System

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 Class 2 Device Recall ARTIS PhenoInterventional Fluoroscopic XRay Systemsee related information
Date Initiated by FirmJanuary 24, 2020
Create DateFebruary 20, 2020
Recall Status1 Terminated 3 on July 10, 2020
Recall NumberZ-1340-2020
Recall Event ID 84858
510(K)NumberK163286 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Code Information All serial numbers
FEI Number 2240869
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information ContactSAME
610-219-4834
Manufacturer Reason
for Recall		Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
FDA Determined
Cause 2		Device Design
ActionSiemens issued Urgent Medical Device Correction letter dated January 24, 2020 A via AX064/19/S ( corrective action via AX063/19/S), stating reason for recall, health risk and a corrective action: In the event the robotic stand shows stuttering movements or a squealing noise while initiating movements, do not move the robotic stand and C-arm any longer. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will correct the hardware error by replacing all affected relays and altering the wiring via Update Instruction AX063/19/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented
Quantity in Commerce96 US
DistributionUS Nationwide distribution.
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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