FDA Device

Varian 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

Hazard

The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.

What You Should Do

Remedy

Varian 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.

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Products

Varian 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
Brand
Varian Medical Systems Oncology Systems
UPC
Product Codes: H690002, H694936,   H696287, H695791,   H694466, H696406,   H694937, H697423,   H695540,   H695617,   H695747,   H695780,   H696166

Units Affected

13

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