Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability
FDA device recall Z-0777-05 · posted 2005-04-27 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.
- Action taken
- On 2/4/05, the firm issued letters to all its direct consignees, informing them of the affected product and providing instructions on the device correction.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 170 units
- Distribution
- The firm has indicated that product was released for distribution to 143 direct consignees in US and to 25 foreign countries via international distribution centers. Foreign distribution include: Austr
- Date initiated
- 2005-02-04
- Date posted
- 2005-04-27
- Date terminated
- 2006-08-17
- 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/D-SERIES CLINACS (CLINAC 600 C/D) (K926321) | Varian Assoc., Inc. | 1994-08-09 |
| VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C (K904364) | Varian Assoc., Inc. | 1991-02-27 |
| CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C) (K862645) | Varian Assoc., Inc. | 1986-10-03 |