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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 Recall
Siregraph CF XRay System
see related information
Date Posted November 12, 2009
Recall Status1 Terminated on January 12, 2010
Recall Number Z-0189-2010
Recall Event ID 53494
Premarket Notification
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, Pennsylvania 19355
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Meredith Adams
610-219-6300
Manufacturer Reason
for Recall
possible injury to hand/fingers
FDA Determined
Cause 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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