Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatm
FDA device recall Z-0805-2016 · posted 2016-02-12 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
- Action taken
- Varian sent an Urgent Medical Device Correction letters dated January 11, 2016 to all affected customers. Letters were also sent to Varian Sales and Marketing and Service organizations to notify them of the recall. The letter identified the affected product, problem and actions to be taken. For questions customers were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manager.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 9499
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Albania, Guadeloupe, Norway,Algeria, Guam, Pakistan, Argentina, Guatemala, Panama,Australia, Hong Kong, Paraguay, Austria, Hungary, Peru,Aze
- Date initiated
- 2016-01-11
- Date posted
- 2016-02-12
- Date terminated
- 2017-10-25
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Eclipse Treatment Planning System (K152393) | Varian Medical Systems, Inc. | 2015-09-18 |