Reported May 13, 2020 · Terminated
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf…
Varian Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
Varian Multileaf Collimator [MLC]Millenium Multileaf Collimator [5280120 leaf]High Definition 120
- Multileaf Collimator Model Number(s)product
- code
H54 and H56MLC software version 8.5 -
- Product Usageis 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
- Lot codes and dates
- Model Number(s)product
- code
H54 and H56MLC software version 8.5
- UDIsHD 120 MLC Head Assembly
- UDI00899475002318 80 Leaf Assy, MLC Head
- UDI00899475002325 120 Leaf Assy, MLC Head
- UDI00899475002332
- Amount recalled
- 151 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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