Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..
FDA device recall Z-2702-2011 · posted 2011-06-29 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up to 10%.
- Action taken
- Varian Medical Systems, Inc. Oncology Systems sent a "Urgent Medical Device Correction" letters on May 3, 2011 ***12-12-12, 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 contained recommended actions. For additional information contact Varian Medical Systems, Inc. at 888- 827-4265.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 5201 units ***12-12-12 AMENDED TO: 5448 units***
- Distribution
- Worldwide distribution; Nationwide (USA) and the countries of Vietnam, Venezuela, United Kingdom, United Arab Emirates, Ukraine, Turkey, Tunisia, Trinidad and Tobago, Thailand, Taiwan, Syria, Switzerl
- Date initiated
- 2011-05-03
- Date posted
- 2011-06-29
- Date terminated
- 2014-07-09
- Location
- Palo Alto, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECLIPSE TREATMENT PLANNING SYSTEM (K073020) | Varian Medical Systems, Inc. | 2007-12-19 |