Varian brand C-Series Clinacs and Acuity, Exact Couch Top, Model Numbers: H69, Product is manufactured and distributed b
FDA device recall Z-1003-2011 · posted 2011-02-01 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 13
- Distribution
- Worldwide Distribution - Japan only
- Date initiated
- 2010-04-19
- Date posted
- 2011-02-01
- Date terminated
- 2011-12-23
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339) | Varian Medical Systems, Inc. | 2003-12-30 |
| VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C (K904364) | Varian Assoc., Inc. | 1991-02-27 |