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Terminated

Varian Medical System TrueBeam system for stereotactic radiosurgery and radiotherapy. Model number H19;

FDA Recall Z-2181-2011 · Posted 2011-05-10

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-04-05
Date Terminated2012-06-19
Product Quantity20

Reason for Recall

Position sensor failure mode may result in an inaccurate position calculation. 1. The video returned by one of the two cameras inside the Spectra is all white or all black, and the Spectra stops tracking. Or 2. Certain video intensities are not available on one of the two cameras. The image has abnormally abrupt transitions from dark to light portions, without the normal shades of gray.

Firm Action

Varian Urgent Medical Device Correction, Urgent Field Safety Notice letters were sent to all affected facilities by certified mail on April 5, 2011.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092871TRILOGY MXVarian Medical Systems, Inc. · 2009-11-30

Official Source

View FDA Recall →

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

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