Company: CHG Hospital Beds Inc. Date of Enforcement Report 3/23/2016 Class lI: PRODUCT The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading...Read More

Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.) Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.. Recall Number Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide...Read More

Company: Mckesson Medical Immaging Date of Enforcement Report 3/23/2016 Class lI: PRODUCT McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. Recall Number Z-1182-2016 REASON McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue...Read More

Company:Roche Diagnostics Operations, Inc. Date of Enforcement Report 3/23/2016 Class lI: PRODUCT Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling...Read More