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U.S. Department of Health and Human Services

Class 2 Device Recall Varian brand CSeries Clinacs and Acuity, Exact Couch Top

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 Class 2 Device Recall Varian brand CSeries Clinacs and Acuity, Exact Couch Topsee related information
Date Initiated by FirmApril 19, 2010
Date PostedFebruary 01, 2011
Recall Status1 Terminated 3 on December 23, 2011
Recall NumberZ-1003-2011
Recall Event ID 56349
510(K)NumberK033339 K904364 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductVarian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed by: Varian Medical Systems Inc., Palo Alto, CA
Code Information Product Codes: H690002, H694936,   H696287, H695791,   H694466, H696406,   H694937, H697423,   H695540,   H695617,   H695747,   H695780,   H696166   
Recalling Firm/
Manufacturer		 Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact
650-424-5731
Manufacturer Reason
for Recall		The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
FDA Determined
Cause 2		Labeling mix-ups
ActionVarian issued via customer technical bulletin on April 19, 2010, to Varian Sales, Marketing and Service organization. Notification. The bulletin identified the product, the problem, and the action to be taken by the customer. Customers were asked to fill out the attached form and send it to their local Varial Medical Systems Field Service Office. For questions regarding this recall call 650-483-3153.
Quantity in Commerce13
DistributionWorldwide Distribution - Japan only
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 = IYE
510(K)s with Product Code = IYE
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