Device Recall AlignRT Plus private labelOSMS Varian

Serial Number of the device(s) distributed 248-016 248-021 248-022 248-030 248-038 248-041 248-063 248-064 249-1514 249-1516 248-071 249-0239 248-073 248-080 248-084 249-0043 249-0055 249-0056 249-0058 249-0069 249-0130 249-0137 249-1509 249-0141 249-0275 249-0152 249-0162 249-0169 249-0251 249-0253 249-0254 249-0288 249-1503 249-1512 249-1518 249-TBD 249-0061 249-0131 249-0256 249-0289 249-0290 249-TBD 248-083 249-0273 249-0276 249-1500 249-1519

Radiology Devices

2

No

Product distributed in US. The foreign countries where the product was distributed are as follows: Canada, Germany, Japan, Sweden, Switzerland, Taiwan, and United Kingdom. No product was distributed to US government accounts.

AlignRT¿ Plus [private label-OSMS] K123371: 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.