Recall Z-2149-2016 ยท IYE Accelerator, Linear, Medical
Varian Medical Systems, Inc.
Optical Surface Monitoring System{OSMS, Varian Private Label} 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.
| Date | Jul 11, 2016 (initiated Jun 23, 2016) |
| Status | Terminated |
| 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]. |
| Root cause | Software design |
| Action | The firm, Visionrt, sent an "URGENT MEDICAL DEVICE CORRECTION NOTIFICATION-URGENT FIELD SAFETY NOTIFICATION" letter dated June 24, 2016 to all affected customers. Letters describe the product, problem and actions to be taken. The customers were instructed as follows: DO NOT USE the "Move Couch" function if the couch rotation value set in the AlignRT device DOES NOT match the planned couch rotation for the treatment field; retain a copy of this document along with your most current product labeling; pass the letter to all those who need to be aware of it within their organization; always confi |
| Quantity | 166 OSMS in US, 23 OSMO - International, |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Austria, Azerbaijan, Brunei Darussalam, Bulgaria, Denmark, Georgia, Germany, India, Italy, Malaysia, Morocco, Norway, Portugal, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123371 | ALIGNRT PLUS Vision RT Limited, Jan 8, 2013 |