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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
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/
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
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.