Recall Z-1729-2009 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems Oncology Systems
Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto, CA. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy.
| Date | Aug 27, 2009 (initiated May 29, 2009) |
| Status | Terminated |
| Reason | Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly. |
| Root cause | Device Design |
| Action | Varian Medical Systems issued an "Urgent Medical Device Correction" dated May 29, 2009 distributed to all affected users, as well as Varian Sales, Marketing and Service organizations, informing them of the issue. Consignees were informed that a Varian Service representative will be in contact to schedule the proper correction. For further questions, contact your local Varian Customer Support District Manager. |
| Quantity | 1,933 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904364 | VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C Varian Assoc., Inc., Feb 27, 1991 |