FDA Device recall Z-0187-2013
ARIA Radiation Oncology, Version 11
- FDA Device
- Class II
- terminated
- Published 2012-11-07
On 2012-11-07 the FDA classified a Class II recall of ARIA Radiation Oncology, Version 11 by Varian Medical Systems Oncology Systems, citing an anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0187-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-24 |
| Published | 2012-11-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems Oncology Systems |
| Distribution | US |
Product
ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application.
Reason
An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued.
Identifiers
| code_info | Model number: HIT Serial numbers: HIT0027 HIT1430R3 HIT2208R3 HIT3513 HIT2546 HIT2546 HIT2546 HIT0028 HIT1470M HIT2208…Model number: HIT Serial numbers: HIT0027 HIT1430R3 HIT2208R3 HIT3513 HIT2546 HIT2546 HIT2546 HIT0028 HIT1470M HIT2208R4 HIT3679 HIT2591 HIT2591 HIT2591 HIT0032 HIT1470R1 HIT2208R5 HIT3910 HIT2615 HIT2615 HIT2615 HIT0134 HIT1470R2 HIT2212 HIT3927M HIT2643 HIT2643 HIT2643 HIT0155 HIT1523M HIT2237M HIT3927R1 HIT2645 HIT2645 HIT2645 HIT0170M H1T1523R1 HIT2237R1 HIT3927R2 HIT2834 HIT2834 HIT2834 HIT0170R1 HIT1587M HIT2267M HIT3967 HIT2865 HIT2865 HIT2865 HIT0170R2 HIT1587R1 HIT2267R1 HIT4014 HIT2894M HIT2894M HIT2894M HIT0170R3 HIT1587R2 HIT2275M HIT4116 HIT2894R1 HIT2894R1 HIT2894R1 HIT0182 HIT1587R3 HIT2275R1 HIT4118M HIT2894R2 HIT2894R2 HIT2894R2 HIT0183 HIT1587R4 HIT2275R2 HIT4118R1 HIT2894R3 HIT2894R3 HIT2894R3 HIT0191M HIT1589M HIT2275R3 HIT4381 HIT2943 HIT2943 HIT2943 HIT0191R1 HITI589R2 HIT2275R4 HIT4555 HIT2953 HIT2953 HIT2953 HIT0191R2 HITI589R3 HIT2291M HIT4592 HIT2997 HIT2997 HIT2997 HIT0227 HIT1589R4 HIT2291R1 HIT4627 HIT3088M HIT3088M HIT3088M HIT0339M HIT1589R5 HIT22 |
|---|
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-0187-2013%22
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