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
This recall has been terminated (originally issued February 1, 2011).
- Recall Initiated
- April 19, 2010
- Posted
- February 1, 2011
- Terminated
- December 23, 2011
- Recall Number
- Z-1003-2011
- Quantity
- 13
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
Distribution
Worldwide Distribution - Japan only
Lot / Code Info
Product Codes: H690002, H694936, H696287, H695791, H694466, H696406, H694937, H697423, H695540, H695617, H695747, H695780, H696166
Root Cause
Labeling mix-ups
Action Taken
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.