Varian Multileaf Collimator [MLC] — Class II medical device recall Z-1899-2020
Terminated recall by Varian Medical Systems, Inc., reported 2020-05-13, distributed nationwide. After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf colli
| Recall number | Z-1899-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc., Palo Alto, CA, United States |
| Recall initiated | 2019-08-12 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2021-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 151 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00899475002318, 00899475002325, 00899475002332 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1899-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.