Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended f
FDA device recall Z-2978-2011 · posted 2011-08-10 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.
- Action taken
- Varian Medical Systems sent an "Urgent Medical Device Correction-Urgent Field Safety Notice" letter dated May 26, 2011 to all affected customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters identifies the product, describes the problem and provides recommendations. Varian recommends maintenance only be performed by qualified personnel with appropriate training, always verify collimator calibration and anytime a collimator posthion readout calibration is performed, and always verify that the collimator angle is not calibrated in reverse by performing the appropriate checks. For questions contact Varian at (888) 827-4265.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 5685
- Distribution
- Worldwide Distribution: Nationwide (USA) Distribution and the countries of; Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Belorussia, Bolivia, Bosnia and He
- Date initiated
- 2011-05-26
- Date posted
- 2011-08-10
- Date terminated
- 2012-07-13
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN HIGH ENERGY LINEAR ACCELERATOR (K100890) | Varian Medical Systems | 2010-07-13 |
| TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K033343) | Varian Medical Systems, Inc. | 2003-12-23 |