Day

June 12, 2019
Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report: 6/12/2019 Class III PRODUCT 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 – Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Recall Number: Z-1699-2019 REASON Power Logic Board Fail Message on the...
Read More
Company: Philips North America, LLC Date of Enforcement Report: 6/12/2019 Class II PRODUCT IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 – Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected...
Read More
Company: Flowonix Medical Inc Date of Enforcement Report: 6/12/2019 Class II PRODUCT Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion. Recall Number: Z-1712-2019 Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For...
Read More
This content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. A SoftwareCPR example for software release note and revision history.  Software Revision Level History Example
Read More

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.