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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 Recall
Siemens MULTIX FUSION
see related information
Date Posted April 24, 2014
Recall Status1 Open
Recall Number Z-1505-2014
Recall Event ID 67568
Premarket Notification
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, Pennsylvania 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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 = KPR and Original Applicant = SIEMENS MEDICAL SOLUTION
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