Eclipse Treatment Planning System; Varian Medical Systems, Palo Alto, CA Radiotherapy treatment for patients with malign
FDA device recall Z-2788-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- A software anomaly has been identified with the Eclipse Monte Carlo (eMC) algorithm where not-equidistant data points in the open beam profile used during configuration may lead to inaccurate results.
- Action taken
- Varian sent an URGENT MEDICAL DEVICE CORRECTION letter via certified mail dated May 20, 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 letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the product from use and advise users to manually initiate the configuration process for resampling to be applied when a previous calculation model is copied. Customers were asked to sign and return the notice to confirm receipt. For questions call USA and Canada 1-888-827-4265 For Europe call +41 41 749 8844
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 10,356
- Distribution
- Worldwide Distribution - USA (nationwide)
- Date initiated
- 2011-05-20
- Date posted
- 2011-07-11
- Date terminated
- 2012-07-13
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE TREATMENT PLANNING SYSTEM (K102011) | Varian Medical Systems, Inc. | 2010-09-03 |