FDA Recall
Terminated
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
Recall: Z-1003-2011
·
Initiated April 19, 2010
Recall
- Recall Number
- Z-1003-2011
- Event Number
- 56349
- Firm
- Varian Medical Systems Oncology Systems
- FEI Number
- 2916710
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- April 19, 2010
- Posted
- February 1, 2011
- Terminated
- December 23, 2011
- Address
- 911 Hansen Way, Palo Alto, CA, 94304-1028
Description
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
Reason
The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
Action
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.
Distribution
Worldwide Distribution - Japan only
Quantity
13