Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems
This recall has been terminated (originally issued November 8, 2007).
- Company
- Varian Medical Systems, Inc.
- Recall Initiated
- June 25, 2007
- Posted
- November 8, 2007
- Terminated
- February 4, 2008
- Recall Number
- Z-0213-2008
- Quantity
- 14 units
- Firm Location
- Palo Alto, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---
Lot / Code Info
Ximatron Digital Imaging v7.5.51.6 SP2, serial numbers: H720441, H720637, H720672, H720702, H720781, H720791, H720804, H720865, H720873, H720894, H720895, H720916, H720932, H720973
Root Cause
Software design
Action Taken
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.