Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Syst
FDA device recall Z-0213-2008 · posted 2007-11-08 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- 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.
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPQ
- Quantity affected
- 14 units
- Distribution
- Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---
- Date initiated
- 2007-06-25
- Date posted
- 2007-11-08
- Date terminated
- 2008-02-04
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP (K851653) | Varian Assoc., Inc. | 1985-05-23 |