Recall Z-0777-05 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Inc
Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability
| Date | Apr 27, 2005 (initiated Feb 4, 2005) |
| Status | Terminated |
| Reason | Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 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: Australia, Bahrain, Belgium, Canada, Czech Republic, Egypt, Finland, France, Germany, Iceland, India, Is |
| FDA record | Open on fda.gov |