True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Varian Medical Systems, Palo Alto, CA. Product Usage: Tr

FDA device recall Z-1495-2012 · posted 2012-05-08 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam.

Action taken

Varian sent an Urgent Medical Device Correction - Urgent Field Safety Notice dated April 13, 2012 to all affected customers. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter identified the affected product, description of problem, details and recommended user actions. Varian will provide a software version that will mitigate the issue described in the letter and Varian Customer Support will notify each affected facility when the software is available. The letter instructs customers to retained a copy of this notice along with the most current product labeling. For future reference, this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. For questions contact Varian Oncology Help Desk at 1-888-827-4265 US and Canada.

Root cause

Device Design

Status

Terminated

Product code

IYE

Quantity affected

207 devices ***12-12-12 AMENDED TO: 216 UNITS***

Distribution

Worldwide Distribution - USA Nationwide and the countries ofAustralia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, Norway, Portugal, Russia

Date initiated

2012-04-09

Date posted

2012-05-08

Date terminated

2014-04-16

Location

Palo Alto, CA

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