Varian Treatment version 6.6.5052. Varian Medical Systems, Palo Alto, Ca Intended to provide accurate treatment set-ups
FDA device recall Z-3105-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Potential for Varian Treatment application failing to load the physical wedge filter for a treatment field on a Siemens Mevatron linear accelerator. Delivery of a treatment field without the planned wedge would deliver more dose than intended and would change the shape of the dose distribution for that field.
- Action taken
- Varian Medical Systems sent out "Urgent Medical Device Correction/Urgent Field Safety Notice" letters dated July 20, 2011 to all affected customers. The letter identified product, problem and provided recommended user actions when setting up and running the system. It also asked customers to notify appropriate personal provided instructions. For information or questions on this recall please call Varian at (888) VARIAN5 (888- 827-4265).
- Root cause
- Other
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 118
- Distribution
- Worldwide Distribution: Nationwide distribution including the states of AZ, CA, FL, GA, IN, MA, MD, MI, MN, MO, NJ, NY, PA, SC, TN, VA and WV; and the countries of Canada, Austria, Belgium, Brazil, De
- Date initiated
- 2011-07-20
- Date posted
- 2011-08-31
- Date terminated
- 2013-12-05
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN TREATMENT (K093967) | Varian Medical Systems, Inc. | 2010-07-12 |