Company: Varian Medical Systems Date of Enforcement Report 7/20/2016 Class lI: 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.. Recall...Read More

Company: Varian Medical Systems Date of Enforcement Report 7/20/2016 Class lI: PRODUCT 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....Read More

Company: Novarad Corporation Date of Enforcement Report 7/20/2016 Class lI: PRODUCT NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS). Recall Number Z-2151-2016 REASON Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. RECALLING FIRM/MANUFACTURER Novarad Corporation , American...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 7/20/2016 Class lI: PRODUCT Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. Recall Number Z-2159-2016 REASON Potential data loss occurs as a result of product archiving not working properly. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc, Hartland, WI on 1/31/16 Voluntary: Firm Initiated...Read More