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Class 2 Device Recall Siregraph CF XRay System |
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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
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Product Classification |
System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
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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/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
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For Additional Information Contact |
Roland Richter 610-448-1777
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Manufacturer Reason for Recall |
X-ray tube movement when table is tilted more than 90 degrees
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FDA Determined Cause 2 |
Other |
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
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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.
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510(K) Database |
510(K)s with Product Code = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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