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Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM...Read More

Company:Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/16/2018 Class lI: PRODUCT ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.. Recall Number: Z-1200-2018 REASON The ECG signal may flatline due to electromagnetic interference during the use of electrosurgical equipment. RECALLING FIRM/MANUFACTURER Siemens Medical...Read More

Company:Inpeco S.A. Date of Enforcement Report 5/16/2018 Class lI: PRODUCT FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System Recall Number: Z-1798-2018 REASON Module may freeze without generating user warning. There is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients RECALLING FIRM/MANUFACTURER Inpeco S.A....Read More