Varian Medical Systems Oncology Systems High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator.
Brand
Varian Medical Systems Oncology Systems
Lot Codes / Batch Numbers
Serial Number 1009.
Products Sold
Serial Number 1009.
Varian Medical Systems Oncology Systems is recalling High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Softwar due to Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Dose Calculation Error: Software anomaly may result in failure of a MLC leaf to reach planned position, potentially resulting in misadministration of dose to a patient.
Recommended Action
Per FDA guidance
Consignees were notified by a Medical Device Notification letter sent on 01/29/2008. The letter advised users to cease use of the device until a corrected version of the software is available. A representative will contact users to upgrade the application once the revised software has been validated and released for distribution.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026