FDA Device recall Z-1899-2020
Varian Multileaf Collimator [MLC]
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Varian Multileaf Collimator [MLC] by Varian Medical Systems, citing 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 relat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1899-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-12 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
Product
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
Reason
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.
Identifiers
| code_info | Model Number(s): product code: H54 and H56; MLC software version 8.5. UDIs: HD 120 MLC Head Assembly. UDI: 008994…Model Number(s): product code: H54 and H56; MLC software version 8.5. UDIs: HD 120 MLC Head Assembly. UDI: 00899475002318 80 Leaf Assy, MLC Head, UDI: 00899475002325 120 Leaf Assy, MLC Head, UDI: 00899475002332 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1899-2020%22
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