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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 September 23, 2009
Date Posted November 12, 2009
Recall Status1 Terminated 3 on January 12, 2010
Recall Number Z-0189-2010
Recall Event ID 53494
510(K)Number K960266  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033.

Indended use: X-Ray, Fluoroscopic, Image-intensified.
Code Information Model Number 4466033, Serial Numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126.
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern PA 19355
For Additional Information Contact Meredith Adams
610-219-6300
Manufacturer Reason
for Recall		 possible injury to hand/fingers
FDA Determined
Cause 2		 Device Design
Action Siemens Medical Solutions USA, Inc. issued a "Customer Safety Advisory Notice" dated September 11, 2009 to inform customers of the potential hazard to patients when using the Siregraph CF system. For further information, contact Siemens at 1-610-448-4500.
Quantity in Commerce 14 units
Distribution Nationwide Distribution -- FL, IL, MI, 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.
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