Varian Multileaf Collimator Recall Due to Software-Related Leaf Movement Failure
Varian Medical Systems is recalling 151 Multileaf Collimators because a software upgrade caused leaves to fail to move during specific arc treatments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a mechanical failure could lead to unintended radiation exposure, but the source explicitly states that no adverse health consequences have been reported.
Plain-English summary
Varian Medical Systems, Inc. is recalling 151 units of Multileaf Collimators (MLC), including the Millenium and High Definition 120 models, due to a software defect. The issue affects MLC software version 8.5 and involves the collimator leaves failing to move during conformal arc treatments, such as VMAT and RapidArc.
The defect is caused by a transient carriage primary-secondary interlock triggered by a carriage fault immediately preceding the start of the arc treatment. The company identified this issue after a recent software upgrade. The recall covers units distributed worldwide, including across the United States and Canada.
There have been no reports of adverse health consequences resulting from this issue. The recall is limited to MLC software version 8.5 and does not affect other treatment types or software versions.
The recalled product
- 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…
- Manufacturer
- Varian Medical Systems, Inc.
- Affected units
- 151
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number(s): product code: H54 and H56
- MLC Head
- UDI: 00899475002325 120 Leaf Assy
- UDI: 00899475002332
Distribution
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