Varian High Energy Linear Accelerator: Varian Medical Systems, Palo Alto, CA 94304 Indicated for stereotactic radiosurge
FDA device recall Z-1045-2011 · posted 2011-02-08 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly was identified whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification.
- Action taken
- An Urgent Medical Device Correction letter was sent to all affected users with a description of the problem and user corrective action steps. Letters were sent on 12/10/2010. Users are to immediately investigate any unusual noises coming from the affected product and report them to whoever is responsible for servicing the device. For customers that do have a service contract with Varian, Varian service will perform an inspection of the counterweight bolts as part of the regular Periodic Maintenance Inspection procedure. Customers are to advice the appropriate personnel of the contents of the letter. For further clarification, customers can contact their local Varian Customer Support Services Manager.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 1882
- Distribution
- Worldwide Distribution.
- Date initiated
- 2010-12-10
- Date posted
- 2011-02-08
- Date terminated
- 2011-08-02
- 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 |
|---|---|---|
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890) | Varian Medical Systems | 2010-07-13 |