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Terminated

Ximatron Digital Imaging (Ximavision), V 7.5.51 with Service Pack (SP), Oncology Information System, Varian Medical Systems

FDA Recall Z-0213-2008 · Posted 2007-11-08

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeKPQ
Date Initiated2007-06-25
Date Terminated2008-02-04
Product Quantity14 units

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution-USA (MO and NY medical centers) and countries of Switzerland, Bahrain, Canada, France, Germany, Japan, Norway and Sweden.---

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K851653VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOPVarian Assoc., Inc. · 1985-05-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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