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U.S. Department of Health and Human Services

Class 2 Device Recall SOMATOM Scope Power

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  Class 2 Device Recall SOMATOM Scope Power see related information
Date Initiated by Firm November 22, 2016
Create Date June 21, 2017
Recall Status1 Terminated 3 on May 30, 2017
Recall Number Z-0920-2017
Recall Event ID 75860
510(K)Number K151749  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product SOMATOM Scope Power, Computed tomography x-ray system
Code Information Model # 10967888 Serial Number:59376 91766 91767 115456 115454 59380 77560 98840 77557 91758 59377 59378 115451 
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Marlynne Galloway
610-448-6471
Manufacturer Reason
for Recall		 Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens mailed on December 01, 2016 a Customer Safety Notice to affected customers to inform them of a corrective action that is being performed to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the effect the issue has on the system, the associated risks and actions they will take to correct the issue. In addition, customers will receive a Customer Safety Notice via Hand Delivery from the Siemens Customer Service Engineer at the scheduled appointment for the corrective installation.
Distribution Distributed to: IL IL GA SC SD OK NY MI IN MD AR
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 = JAK and Original Applicant = Siemens Medical Solutions USA, Inc.
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