Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/8/2017 Class lI: PRODUCT Syngo.plaza, picture archiving and communications system. Recall Number Z-1116-2017 REASON Software update for improvements and to resolve several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 1/11/2017 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/8/2017 Class lI: PRODUCT Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation....Read More
Company: Mevion Medical Systems, Inc.. Date of Enforcement Report 2/8/2017 Class lI: PRODUCT MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy Recall Number Z-1122-2017 REASON An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened RECALLING FIRM/MANUFACTURER Mevion Medical Systems, Inc., Littleton, MA on...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.