TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. Tru

FDA device recall Z-1175-2012 · posted 2012-03-06 · Terminated

Recall details

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Reason for recall

An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning.

Action taken

Urgent Medical Device Correction/Urgent Field Safety Notices were sent on January 30, 2012 by certified mail to US and Canadian consignees. ***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.*** Varian Sales, Marketing and Service Organizations also were informed via letter the same day. The Field Safety Notice with customer distribution list was e-mailed to Varian International Customer Support Managers for translation (if necessary) to be sent to affected sites with return proof of notification to be sent to Varian. The notice informed users of the recommended actions. Questions were directed to the Varian Help Desk 1-888-827-4265 (US and Canada).

Root cause

Device Design

Status

Terminated

Product code

IYE

Quantity affected

182 units ***12-12-12 AMENDED TO: 200 units***

Distribution

Nationwide Distribution (USA) and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, New Zealand, Norway, Russia, Saud

Date initiated

2012-01-30

Date posted

2012-03-06

Date terminated

2014-04-16

Location

Palo Alto, CA

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