Varian Medical Systems Floorstand. An accessory of the Optical Guidance Platform, Model number HZ5 for use with a charge
FDA device recall Z-0888-2011 · posted 2011-01-10 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.
- Action taken
- Varian sent an urgent device correction notification letter 01/26/2009 to all affected users, with a description of the problem and user corrective action steps via certified mail. The letter will also be distributed to Varian Sales, Marketing and Service organizations.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 3 units
- Distribution
- Product was distributed to 3 consignees in Florida and Wisconsin.
- Date initiated
- 2009-01-26
- Date posted
- 2011-01-10
- Date terminated
- 2012-02-24
- 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 |
|---|---|---|
| OPTICAL GUIDANCE PLATFORM (K071360) | Varian Medical Systems, Inc. | 2007-06-08 |