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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Medical Somatom Computed Tomography System

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  Class 2 Device Recall Siemens Medical Somatom Computed Tomography System see related information
Date Initiated by Firm July 10, 2002
Date Posted December 05, 2002
Recall Status1 Terminated 3 on March 24, 2003
Recall Number Z-0322-03
Recall Event ID 25075
510(K)Number K013522  
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Computed Tomography system, Diagnostic Imaging:

Somatom Sensation 4
Somatom Volume Zoom
Somatom Volume Access
Somatom Balance
Somatom Emotion
Somatom Emotion Duo
Somatom Esprit
Somatom Esprit +
Code Information Somatom Sensation 4 -- Serial Numbers 28001 to 28070 Somatom Volume Zoom -- Serial Numbers 24006 to 24752 Somatom Volume Access -- Serial Numbers 26111 to 26123 Somatom Valance -- Serial Numbers 38169 to 38475 Somatom Emotion -- Serial Numbers 40354 to 40383 Somatom Emotion Duo -- Serial Numbers 36081 to 36126 Somatom Esprit -- Serial Numbers 34191 to 34213 Somatom Esprit+ -- Serial Numbers 35024 to 35039
Recalling Firm/
Manufacturer		 Siemens Medical Systems Inc
186 Wood Ave So
Iselin NJ 08830
For Additional Information Contact Roland Richter
732-321-4835
Manufacturer Reason
for Recall		 Head holder cannot be properly secured on the table top.
FDA Determined
Cause 2		 Other
Action Siemens sent all customers a Update Instruction CT016/02/S document alerting them to the problem. This is their recall notification.
Quantity in Commerce 250
Distribution The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175 units were distributed to 45 different countries worldwide.
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 SYSTEMS, INC.
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