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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom Artis systems with Motor Controller Unit

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 Class 2 Recall
Axiom Artis systems with Motor Controller Unit
see related information
Date Posted May 28, 2010
Recall Status1 Terminated on April 11, 2013
Recall Number Z-1732-2010
Recall Event ID 55647
Premarket Notification
510(K) Number
K021021 
Product Classification Solid State X-Ray Imager (Flat Panel/Digital Imager) - Product Code MQB
Product Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.
Code Information Model Numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717 and 7728392.
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
51 Valley Stream Pkwy
Malvern, Pennsylvania 19355
For Additional Information Contact Customer Service
610-219-6300
Manufacturer Reason
for Recall
sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.
FDA Determined
Cause 2
DESIGN: Device Design
Action Siemens issued an "Urgent Field Safety Notice" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance. For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237.
Quantity in Commerce 83 units
Distribution Nationwide Distribution
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 = MQB and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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