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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-1475-04
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 4466033
Code Information Serial numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1572, 1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126.
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 15 units
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.