Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C,C/D E
FDA device recall Z-0194-2007 · posted 2006-11-16 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- The chain holding the device gantry in position may break.
- Action taken
- On 8/31/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 254 units
- Distribution
- Worldwide, including USA, England, Taiwan, Switzerland, Sweden, South Korea, Portugal, Poland, Norway, New Zealand, Netherlands, Malaysia, Japan, Italy, Germany, France, Denmark, Czech Republic, Colom
- Date initiated
- 2006-08-31
- Date posted
- 2006-11-16
- Date terminated
- 2007-12-04
- 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 |
|---|---|---|
| VARIAN C-SERIES CLINACS (CLINAC 2300C/D) (K913119) | Varian Assoc., Inc. | 1991-11-07 |
| MODEL SW-103 SOLITANS STIMULATOR (K904264) | Medical Consultants Intl. , Ltd. | 1991-05-09 |