Recall Z-0945-2012 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc. Oncology Systems
Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therap
| Date | Feb 3, 2012 (initiated Nov 10, 2011) |
| Status | Terminated |
| Reason | Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted. |
| Root cause | Device Design |
| Action | The firm, Varian Medical Systems, Inc., sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" letter dated November 10, 2011 to all affected users. The letter describes the product, description of problem, details, recommended actions and Varian's actions. Varian Service will contact customers to arrange installation, once modifications are available. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter also included special instructions for customers outside the USA an |
| Quantity | 205 units***12-12-12 AMENDED TO: 213 units*** |
| Distribution | Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Algeria, Austria, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Ph |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990085 | MILLENNIUM MLC -120 Varian Assoc., Inc., Feb 8, 1999 |