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U.S. Department of Health and Human Services

Class 2 Device Recall ARTIS Pheno Interventional Fluoroscopic XRay System

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  Class 2 Device Recall ARTIS Pheno Interventional Fluoroscopic XRay System see related information
Date Initiated by Firm May 01, 2018
Create Date June 22, 2018
Recall Status1 Terminated 3 on March 18, 2020
Recall Number Z-2283-2018
Recall Event ID 80272
510(K)Number K163286  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
Code Information 164033 164071 164034 164095 164057 164055 164054 164080 164072 164088 164048 164094 164068 164019 164013 164073 164027 164026 164025 164060 164083 164021 164066 164075 164084 164086 164074 164098 164028 164053 164063 164064 164024 164049 164022 164018 164100 164097 164011 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Ms. Meredith Adams
610-448-6461
Manufacturer Reason
for Recall		 If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
FDA Determined
Cause 2		 Device Design
Action On May 1, 2018, the firm distributed Urgent Medical Device Correction letters to its affected customers. The letter instructed customers to follow standard emergency procedures they have in place in the event of system failures. The firm recommended considering reinforcing the emergency procedures until the update has been completed. As an immediate measure, operators were instructed to avoid driving the C-arm into a fully extended longitudinal position. The firm is currently developing a solution to eliminate the root cause of the problem. The solution will be distributed to all affected customers upon completion. Customers were asked to forward the safety information to any other organizations that could be affected.
Quantity in Commerce 39
Distribution Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
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.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = SIEMENS MEDICAL SOLUTION USA, INC.
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