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 defin
Check against the official notice below — it lists the full affected range.
Varian Medical Systems is recalling 151 units of its Multileaf Collimator devices (Millennium and High Definition models with product codes H54 and H56) that received a software upgrade to version 8.5. After the upgrade, the collimator leaves failed to move during arc treatments, including VMAT and RapidArc procedures. The problem stems from a transient carriage interlock issue related to a carriage fault that occurs immediately before arc treatment begins. This issue only affects software version 8.5 and only impacts conformal arc treatments. No adverse health consequences have been reported from this defect.
The affected devices were distributed worldwide, including throughout numerous U.S. states and Canada. The record does not specify a remedy or instructions for consumers regarding what action should be taken.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution - US Nationwide distribution including in the states of TN, FL, IN, PA, NV, WA, DC, CA, AL, IL, MD, VA, TX, MN, AR, GA, OR, MS, MO, NY, SC, DE, AZ, NH, MI, NC, OH, PA and OK. The country of Canada. Quantity: 151 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.