FDA Device recall Z-0867-2013
Varian Eclipse Treatment Planning System for Radiotherapy
- FDA Device
- Class II
- terminated
- Published 2013-02-27
On 2013-02-27 the FDA classified a Class II recall of Varian Eclipse Treatment Planning System for Radiotherapy by Varian Medical Systems Oncology Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0867-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-28 |
| Published | 2013-02-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems Oncology Systems |
| Distribution | US |
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.
Identifiers
| code_info | H480044 , H481353 , H482733 , H484585 , H485948 , H480045 , H481354 , H482734 , H484634 , H486024 , H480105 , H481433…H480044 , H481353 , H482733 , H484585 , H485948 , H480045 , H481354 , H482734 , H484634 , H486024 , H480105 , H481433 , H482765 , H484673 , H486032 , H480106 , H481436 , H482827 , H484677 , H486093 , H480159 , H481437 , H482858 , H484680 , H486094 , H480160 , H481451 , H482859 , H484745 , H486095 , H480247 , H481452 , H482860 , H484746 , H486114 , H480301 , H481453 , H482888 , H484747 , H486140 , H480373 , H481454 , H482889 , H484753 , H486209 , H480374 , H481460 , H482897 , H484830 , H486291 , H480378 , H481461 , H483087 , H484842 , H486369 , H480379 , H481462 , H483204 , H484856 , H486385 , H480408 , H481483 , H483345 , H484950 , H486412 , H480409 , H481532 , H483350 , H484951 , H486442 , H480410 , H481533 , H483351 , H48SOOS , H486473 , H480422 , H481581 , H483352 , H485006 , H486486 , H480471 , H481582 , H483353 , H485090 , H486498 , H480477 , H481601 , H483354 , H485091 , H486499 , H480493 , H481627 , H483406 , H485113 , H486543 , H480566 , H481639 , H483442 , H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Varian Medical Systems Oncology Systems
- Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Vari…
FDA Device · Class II · 2013-05-22 · Varian Medical Systems Oncology Systems - Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 Product Usage: The RPM device is to be used…
FDA Device · Class II · 2013-05-01 · Varian Medical Systems Oncology Systems - Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Af…
FDA Device · Class II · 2012-12-26 · Varian Medical Systems Oncology Systems - ARIA Radiation Oncology, Version 11
FDA Device · Class II · 2012-11-07 · Varian Medical Systems Oncology Systems - Varian brand Eclipse Treatment Planning System, Model Number: H48
FDA Device · Class II · 2012-10-03 · Varian Medical Systems Oncology Systems
All Varian Medical Systems Oncology Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0867-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.