Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/11/2016 Class lI: PRODUCT Syngo Dynamics; Kinetdx Picture Archiving and Communications System Recall Number Z-1601-2016 REASON Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/11/2016 Class lI: PRODUCT ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816. Recall Number Z-1592-2016 REASON While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to...Read More

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure .Date of Enforcement Report 5/11/2016 Class lI: PRODUCT Medtronic CareLink” Monitor (2490C) and Medtronic CareLink Express” Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network...Read More

Company: Carestream Health, Inc. Date of Enforcement Report 5/11/2016 Class lI: PRODUCT CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image...Read More

Company: Carestream Health, Inc. Date of Enforcement Report 5/11/2016 Class lI: PRODUCT CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 — Made in USA by: Carestream Health, Inc. 150 Verona Street, Rochester, NY...Read More

Company: CareFusion 303 Inc..Date of Enforcement Report 5/11/2016 Class lI: PRODUCT Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.. Recall Number Z-1606-2016 REASON The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the...Read More