Varian Medical Systems Inc Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems
Brand
Varian Medical Systems Inc
Lot Codes / Batch Numbers
Ximatron Digital Imaging v7.5.51.6 SP2, serial numbers: H720441, H720637, H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895, H720916, H720932, H720973
Products Sold
Ximatron Digital Imaging v7.5.51.6 SP2, serial numbers: H720441, H720637, H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895, H720916, H720932, H720973
Varian Medical Systems Inc is recalling Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, due to Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an M. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unexpected loss of Treatement Field Add-Ons (Wedges, Blocks, etc) during Ximatron simulation. If an unapproved treatment field is created without an MLC, but with an add-on, the add on will be deleted without warning. If this is not detected and corrected, incorrect dose delivery will occur.
Recommended Action
Per FDA guidance
The firm issued an Urgent Medical Device Correction letter to its customers by mail on June 25, 2007. It informed consignees of the anomaly in the software and workarounds for the issue. In addition, the firm also stated that they are currently validating a new software modification to repair the problem.
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 noticeDistribution
As reported by FDA
MO, NY
Page updated: Jan 10, 2026