FDA Device recall Z-0552-2014

Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13

FDA Device
Class II
terminated
Published 2014-01-01

On 2014-01-01 the FDA classified a Class II recall of Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13 by Varian Medical Systems, citing an anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose"….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0552-2014
Classification	Class II
Status	terminated
Initiated	2013-11-18
Published	2014-01-01
Last updated	2026-09-13 11:53 UTC
Company	Varian Medical Systems
Distribution	n/a

Product

Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.

Reason

An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.

Identifiers

code_info	Model numbers H48, HIT, H77: Code numbers: H480001 H480164 H480362 H480544 H480717 H480969 H481133 H481323 H481504 H4… Model numbers H48, HIT, H77: Code numbers: H480001 H480164 H480362 H480544 H480717 H480969 H481133 H481323 H481504 H48179S H481969 H482027 H48208S H480004 H48016S H48036S H48054S H48072S H480972 H481134 H481326 H481SOS H481796 H481970 H482028 H482086 H480009 H480174 H480373 H480546 H480727 H480974 H481138 H481327 H481506 H481804 H481971 H482029 H482087 H480010 H480175 H480374 H480547 H480760 H480975 H48114S H481328 H481510 H48180S H481972 H482030 H482088 H480011 H480176 H480378 H480548 H480764 H480980 H481146 H481329 H48152S H481806 H481973 H482031 H482089 H48001S H480181 H480379 H480566 H480765 H480981 H481147 H481334 H481532 H481807 H481974 H482032 H482090 H480030 H480182 H480380 H480578 H480766 H480989 H481148 H48133S H481533 H481815 H481975 H482033 H482091 H480033 H480200 H480381 H480579 H480767 H480992 H481153 H481343 H481540 H481816 H481976 H482034 H482092 H480034 H480207 H480382 H480580 H480769 H480994 H481154 H481352 H481543 H481834 H481977 H482035 H482093 H480035 H4

code_info

Model numbers H48, HIT, H77: Code numbers: H480001 H480164 H480362 H480544 H480717 H480969 H481133 H481323 H481504 H4…

Model numbers H48, HIT, H77: Code numbers: H480001 H480164 H480362 H480544 H480717 H480969 H481133 H481323 H481504 H48179S H481969 H482027 H48208S H480004 H48016S H48036S H48054S H48072S H480972 H481134 H481326 H481SOS H481796 H481970 H482028 H482086 H480009 H480174 H480373 H480546 H480727 H480974 H481138 H481327 H481506 H481804 H481971 H482029 H482087 H480010 H480175 H480374 H480547 H480760 H480975 H48114S H481328 H481510 H48180S H481972 H482030 H482088 H480011 H480176 H480378 H480548 H480764 H480980 H481146 H481329 H48152S H481806 H481973 H482031 H482089 H48001S H480181 H480379 H480566 H480765 H480981 H481147 H481334 H481532 H481807 H481974 H482032 H482090 H480030 H480182 H480380 H480578 H480766 H480989 H481148 H48133S H481533 H481815 H481975 H482033 H482091 H480033 H480200 H480381 H480579 H480767 H480992 H481153 H481343 H481540 H481816 H481976 H482034 H482092 H480034 H480207 H480382 H480580 H480769 H480994 H481154 H481352 H481543 H481834 H481977 H482035 H482093 H480035 H4

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2014%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.