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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 February 13, 2014
Date Posted April 24, 2014
Recall Status1 Terminated 3 on March 16, 2015
Recall Number Z-1505-2014
Recall Event ID 67568
510(K)Number K121513  
Product Classification System, x-ray, stationary - Product Code KPR
Product MULTIX FUSION.

The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
Code Information model nos. 10746665, 10746666, 10847610, 10746700
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Customer Support
610-219-6300
Manufacturer Reason
for Recall		 It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be afixed with transversal carriage, with Loctite 243 and Torque 10nm during system installation. Siemens initiated the update instruction to verify and secure the hose holder with Loctite 243. A PCB D802 Rev. 00 b
FDA Determined
Cause 2		 Process change control
Action Affected customers were initially notified with a recall letter on/about 2/12/14 and were sent Update Instructions to affected customers.
Quantity in Commerce 12
Distribution Distributed in the states of AK, PA, KY, OH, WI, MI, FL, and NY.
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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