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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS pheno

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  Class 2 Device Recall ARTIS pheno see related information
Date Initiated by Firm April 22, 2020
Create Date May 22, 2020
Recall Status1 Terminated 3 on October 09, 2020
Recall Number Z-2108-2020
Recall Event ID 85608
510(K)Number K163286  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product ARTIS Pheno - Interventional Fluoroscopic X-Ray System
Model: 10849000 - Product Usage: 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.
Code Information Serial Numbers: 164011 164013 164018 164019 164021 164022 164024 164025 164026 164027 164028 164033 164034 164048 164049 164053 164054 164055 164057 164060 164061 164063 164064 164066 164068 164069 164071 164072 164073 164074 164075 164080 164083 164084 164086 164088 164094 164095 164097 164098 164100 164105 164113 164115 164121 164124 164125 164132 164134 164138 164140 164142 164152 164153 164155 164157 164158 164159 164160 164161 164163 164168 164171 164172 164173 164183 164184 164186 164187 164188 164189 164190 164196 164201 164202 164204 164205 164210 164211 164212 164213 164216 164227 164228 164231 164234 164240 164241 164242 164244 164250 164253 164257 164263 164267 164269 164270 164271 164275 164277 164279 164282 164287 164292 164293 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer
FDA Determined
Cause 2		 Software design
Action Siemens issued Urgent Medical Device Correction dated 4/22/20 via AX074/19/S. Letter states reason for recall, health risk and action to take: Planned procedures may have to be terminated and performed on an alternative X-ray system. 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 error with a software patch in which the system will recognize a deviation of the intended travel path and unit movements are stopped immediately, similar to the activation of a proximity switch. The correction will be initiated via Update Instruction AX073/19/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 Commerce 105 systems
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTION USA, INC.
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