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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Multix Fusion

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  Class 2 Device Recall Siemens Multix Fusion see related information
Date Initiated by Firm August 03, 2018
Create Date October 30, 2018
Recall Status1 Terminated 3 on November 26, 2019
Recall Number Z-0297-2019
Recall Event ID 81007
510(K)Number K121513  
Product Classification System, x-ray, stationary - Product Code KPR
Product Multix Fusion system is a radiographic system:
Models:
Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059);
Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042);
Multix Fusion Digital Integrated (model number 10746667) with Tube stand 3D V (model number 7042042);
Multix Fusion Digital Wireless (model number 10893300) with Tube stand 3D V (model number 7042042)
Code Information Serial Numbers:  40279 10037 1176 40026 1220 40106 40208 40209 40109 40114 40140 40104 40126 40144 10040 10041 40027 40118 40105 40128 40200 40146 10039 40102 40101 40022 40125 40142 40127 40117 40206 1192 1185 40116 40119  
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall
Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during patient positioning
FDA Determined
Cause 2
Device Design
Action Siemens Healthineers issued Urgent Medical Device Correction notice dated August 3, 2018, informing potentially affected users via Safety Advisory Notice XP029/18/S to advise of the problem, risk to health, action to be taken (it is strongly recommended not to perform up/down movements of the lifting column directly above the patient. Instead, the vertical movement should be completed beside the patient and then the system should be moved horizontally to the patient). The service organization will contact to arrange a date to perform this corrective action with Update Instruction XP031/18/S. Contact service organization for an earlier appointment at 1-800-888-7436. Siemens Healthineers is preparing a corrective action that will resolve this potential issue. The corrective action will be distributed via an Update Instruction XP031/18/S.
Quantity in Commerce 35 units
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 = KPR and Original Applicant = SIEMENS MEDICAL SOLUTION
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