Company: Merge Healthcare, Inc. Date of Enforcement Report 12/7/2016 Class lI: PRODUCT Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 12/7/2016 Class lI: PRODUCT Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications Recall Number Z-0664-2017 REASON Communication protocols interfacing with the affected software version with some select instruments were not properly...Read More

“IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved and released. It can be purchased from the ISO at the link provided. This standard addresses Health Software Products in general and does not attempt to define which are regulated and which are not. Its scope is all standalone software...Read More

Company: Elekta, Inc. Date of Enforcement Report 12/7/2016 Class lI: PRODUCT Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-0660-2017 REASON Incorrect Dose when using the reset function. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta, GA on 11/25/2016 Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More