Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platf
FDA device recall Z-0332-2012 · posted 2011-12-01 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage.
- Action taken
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated October 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are advised to verify that they are using the current design of the head ring posts (part # 970.284) and to contact Varian if replacements are needed. Customers may contact the Varian Help Desk for questions regarding this notice at 1-888-827-4265.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 205 kits ( Each kit contains 4 Head Post Rings) 820 HPR's
- Distribution
- Worldwide Distribution.
- Date initiated
- 2011-10-04
- Date posted
- 2011-12-01
- Date terminated
- 2012-07-25
- 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 |