Company: Spacelabs Healthcare Inc Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number Z-0332-2017 REASON The firm received reports of telemetry...Read More

Company:Hospira Inc.. Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027 Recall Number Z-0354-2017 REASON Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of...Read More

Company:Hospira Inc.. Date of Enforcement Report 11/9/2016 Class lI: PRODUCT Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026 Recall Number Z-0353-2017 REASON Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of...Read More

/docs/FDAMDRGuidance110916ucm359566.pdfRead More

http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm523316.htmRead More