Print-ready dossier — use your browser's print dialog to save as PDF.
120 Leaf Assy, MLC Head
Model 8.5 · VARIAN MEDICAL SYSTEMS, INC. · DI 00899475002332
IYE — Accelerator, Linear, Medical · Class II · 21 CFR 892.5050
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2019-08-12
Z-1899-2020
Class II
Terminated
After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue.
code info di
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
1
2019-03
0
2.67
2019-04
0
2.33
2019-05
0
1.25
2019-07
0
1
2019-08
0
1.2
2019-09
0
4
2019-10
0
3
2019-11
0
1.33
2019-12
0
1.33
2020-01
0
3.6
2020-02
0
1.33
2020-03
0
1.83
2020-04
0
2.67
2020-05
0
4.2
2020-06
0
2.6
2020-07
0
1
2020-08
0
3.4
2020-10
0
4.75
2020-11
0
2.4
2020-12
0
3
2021-01
0
1.33
2021-02
0
1.67
2021-03
0
1.8
2021-04
0
1.8
2021-05
0
1.33
2021-06
0
2
2021-07
0
3.4
2021-08
0
2
2021-09
0
2
2021-10
0
1.17
2021-11
0
2.5
2021-12
0
4.25
2022-01
0
1.6
2022-02
0
1.4
2022-03
0
3.4
2022-04
0
1.33
2022-06
0
2.77
2022-07
0
3
2022-08
0
2.17
2022-09
0
2.17
2022-10
0
1.33
2022-11
0
2.82
2022-12
0
1.17
2023-01
0
4.57
2023-02
0
2.14
2023-03
0
3.57
2023-04
0
10.1
2023-05
0
6.29
2023-06
0
4.4
2023-07
0
3.22
2023-08
0
1.75
2023-09
0
2
2023-10
0
1.33
2023-11
0
2.33
2023-12
0
1.8
2024-01
0
1.17
2024-02
0
1
2024-03
0
1.33
2024-04
0
1.75
2024-05
0
2
2024-06
0
1
2024-07
0
1.6
2024-08
0
1
2024-09
0
1.25
2024-10
0
1.67
2024-11
0
3
2024-12
0
1
2025-01
0
1.6
2025-02
0
1.33
2025-03
0
1.5
2025-04
0
2
2025-05
0
2.67
2025-06
0
5.67
2025-07
0
1.5
2025-08
0
1.25
2025-09
0
1.67
2025-10
0
1
2025-11
0
1
2025-12
0
1
2026-01
0
1.5
2026-02
0
1
2026-03
0
1
2026-04
0
1
2026-05
0
1
2026-06
0
1
This device (reports/month)Average device in IYE (reports/device/month)