Recall Z-2150-2016— Varian Medical Systems, Inc.

Name: FDA recall Z-2150-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-23

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2016-06-23, terminated 2018-08-24. It names one FDA 510(k) clearance: K123371. Product: Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.. Reason: Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS]..

Recalling firm: Varian Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Terminated: 2018-08-24
Firm location: Palo Alto, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123371 — ALIGNRT PLUSVision RT Limited·cleared 2013-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE; Radiology: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to Withhold the beam automatically during radiation delivery.

Reason for recall

Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].

Data sourced from openFDA. This site is unofficial and independent of the FDA.