Recall Z-0332-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Head Ring Posts with part number 970.280 - re-usable components of the Frame Array Module (of the Optical Guidance Platform and Floorstand devices. Varian Medical Systems, Palo Alto, CA 94304. The Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment for stereotactic radiosurgery or radiotherapy treatments on cranial extracranial lesi
| Date | Dec 1, 2011 (initiated Oct 4, 2011) |
| Status | Terminated |
| Reason | An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechanical stress resulting in possible failure during usage. |
| Root cause | Device Design |
| Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" letter dated October 4, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are advised to verify that they are using the current design of the head ring posts (part # 970.284) and to contact Varian if replacements are needed. Customers may contact the Varian Help Desk for questions regarding this notice at 1-888-827-4265. |
| Quantity | 205 kits ( Each kit contains 4 Head Post Rings) 820 HPR's |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071360 | OPTICAL GUIDANCE PLATFORM Varian Medical Systems, Inc., Jun 8, 2007 |