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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 Device Recall Axiom Artis systems with Motor Controller Unitsee related information
Date Initiated by FirmApril 12, 2010
Date PostedMay 28, 2010
Recall Status1 Terminated 3 on April 11, 2013
Recall NumberZ-1732-2010
Recall Event ID 55647
510(K)NumberK021021 
Product Classification Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
ProductAxiom 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 PA 19355
For Additional Information ContactCustomer 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		Device Design
ActionSiemens 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 Commerce83 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MQB
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