TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide s
FDA device recall Z-2766-2011 · posted 2011-07-08 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Imaging arms of the TrueBeam Accelerator may have loose encoder pulleys that could lead to inaccurate readout of arm geometry.
- Action taken
- Varian Medical Systems, Inc. Oncology Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 19, 2011, via certified mail, return receipt requested in the US. The letter identified the product, problem and recommended actions to be taken. For additional information contact Varian Customer Support at 1-888- 827-4265.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 77
- Distribution
- Worldwide Distribution -- USA (nationwide) and countries of: Canada, Denmark, France, Germany, Isreal, Italy, Netherlands, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Date initiated
- 2011-05-19
- Date posted
- 2011-07-08
- Date terminated
- 2012-03-13
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY MX (K092871) | Varian Medical Systems, Inc. | 2009-11-30 |