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U.S. Department of Health and Human Services

Class 2 Device Recall Siregraph CF XRay System

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  Class 2 Device Recall Siregraph CF XRay System see related information
Date Initiated by Firm June 07, 2004
Date Posted September 18, 2004
Recall Status1 Terminated 3 on August 18, 2005
Recall Number Z-1476-04
Recall Event ID 29967
510(K)Number K960266  
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466041
Code Information Serial number: 3131.
Recalling Firm/
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355-1406
For Additional Information Contact Roland Richter
Manufacturer Reason
for Recall
X-ray tube movement when table is tilted more than 90 degrees
FDA Determined
Cause 2
Action The recalling firm issued a Customer DAfety Advisory letter dated 6/7/04 to the hospitals. The letter informs them of the potential problem and provides preventative measures to avoid its occurance.
Quantity in Commerce 1 unit
Distribution The products were shipped to medical facilities in FL, IL, MI, NH, NJ, PA, and TX.
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 = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.