Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Ident
FDA device recall Z-2383-2012 · posted 2012-09-14 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The position readout interlock circuitry will not detect this jaw position deviation. This may lead to treatment with an under-dose of the intended target volume.
- Action taken
- Varian sent an "URGENT MEDICAL DEVICE CORRECTION URGENT FIELD SAFETY NOTICE" dated August 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-888-827-4265 for questions regarding this recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 221 Units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-08-14
- Date posted
- 2012-09-14
- Date terminated
- 2013-12-04
- 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 |
|---|---|---|
| TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE (K081188) | Varian Medical Systems, Inc. | 2008-07-14 |
| VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D) (K926321) | Varian Assoc., Inc. | 1994-08-09 |