Company:Siemens MedicalDate of Enforcement Report 5/8/2013 Class ll: PRODUCT Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of...Read More

Company: GE Healthcare.Date of Enforcement Report: 5/8/2013 Class ll: PRODUCT GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device. Recall Number Z-1207-2013 REASON GE Healthcare has recently become aware of a Reformat Image Flip Issue associated...Read More

Company: GE Healthcare LLCDate of Enforcement Report: 5/8/2013 Class ll: PRODUCT GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device. Recall Number Z-1208-2013 REASON GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from...Read More