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Terminated

LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.

FDA Recall Z-0978-2007 · Posted 2007-06-28

Recalling FirmVarian Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2007-03-09
Date Terminated2012-02-28
Product Quantity80 devices

Reason for Recall

A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. The tilt rotation compensation algorithm does not adequately compensate for the tilt rotation.

Firm Action

The recalling firm notified medical device end users by letter dated 03/09/07 and advised of the software anomaly and provided details for user corrective action pending software upgrade by the manufacturer.

Root Cause

Software design

Distribution Pattern

The medical devices were distributed to medical centers nationwide and worldwide.

Official Source

View FDA Recall →

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

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