Recall Z-0867-2013— Varian Medical Systems, Inc. Oncology Systems
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2013-01-28, terminated 2014-04-04. It names one FDA 510(k) clearance: K102011. Product: Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.. Reason: The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used..
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-28
- Terminated
- 2014-04-04
- Firm location
- Palo Alto, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Reason for recall
The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used.
Data sourced from openFDA. This site is unofficial and independent of the FDA.