Z-1899-2020Class II

Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120...

Name: Z-1899-2020 Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120...
Creator: Varian Medical Systems, Inc.
Published: 2019-08-12
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2019-08-12 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. began a recall of Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code... on 2019-08-12. FDA classified it as Class II and gives the reason as "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-...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1899-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-12
Posted: 2020-05-05
Terminated: 2021-01-21
Recalling firm: Varian Medical Systems, Inc.
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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: Urgent Medical Device Correction Field Safety Notice letters were sent to customer beginning August 12, 2019. Letters were sent to U.S. and Canadian customers via Fed-Ex, and via local third-party courier or email for the rest of the world. Users were instructed to: 1. monitor MLC leaf movement on the 4DITC console screen, 2. observe the start of every arc treatment and verify that the leaves are moving as intended, and 3. stop treatment immediately if MLC leaves are not moving and contact Varian to assess the MLC status. Users may contact Varian Support for help to verify whether carriage faults have been recorded for the MLC. If carriage fault is confirmed in the TerminalLog file, users were instructed to contact Varian Service Representative to assess the MLC status. Customers were requested to complete and return the response form provided to [email protected], and to contact their local Varian Medical Systems service manager with any questions. The notification letter includes Varian Support Information with the following contact information: phone number for North America Customers: 1 888.827.4265; Global email address [email protected]; and website contact address for customers outside of North America: https://www.myvarian.com/s/contactus?lang=en.
Quantity in commerce: 151 units
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1899-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1899-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-05

Product code IYE

K181404Class IIVarian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorVarian Medical Systems, Inc. / cleared 2018-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)