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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/
Siemens Medical Systems Inc
186 Wood Ave So
Iselin NJ 08830
For Additional Information Contact Roland Richter
Manufacturer Reason
for Recall
Head holder cannot be properly secured on the table top.
FDA Determined
Cause 2
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.