Day

August 1, 2018
The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare. There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians. The FDA wants to regulate...
Read More
Company: Human Design Medical LLC Date of Enforcement Report: 8/1/2018 Class III: PRODUCT Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Recall Number: Z-2530-2018 REASON Some Vivo 65 devices have an unreleased version of the Firmware...
Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 7/25/2018 Class II: PRODUCT RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number: Z-2554-2018 REASON The firm has...
Read More
Company: Forte Automation Systems Inc. Date of Enforcement Report: 8/1/2018 Class II: PRODUCT Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of...
Read More
Company: Abbott Laboratories, Inc. Date of Enforcement Report: 8/1/2018 Class II: PRODUCT CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 Recall Number: Z-2522-2018 REASON Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems...
Read More
Also states the new annual registration fees. Keep in mind, businesses with gross revenue under USD $100 million qualify for the reduced small business fees listed.
Read More
Company:Human Design Medical Llc Date of Enforcement Report 8/1/2018 Class lII: PRODUCT Vivo 65, Continuous Ventilator, Home Use, Cat. No. 204000 Product Usage: To provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Recall Number: Z-2530-2018 REASON Some Vivo 65 devices have an unreleased version of the Firmware upgrade...
Read More
Company:RAYSEARCH LABORATORIES AB Date of Enforcement Report 7/25/2018 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 7.0 Product Usage RayStation is a software system designed for treatment planning and analysis of radiation therapy. Recall Number: Z-2554-2018 REASON The firm has learned...
Read More
Company: Forte Automation Systems Inc. Date of Enforcement Report 8/1/2018 Class II: PRODUCT Patient Positioning System with KRC2 controller using software versions 2.3.1 2.3.10 Product Usage: The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of...
Read More
Company: Abbott Laboratories, Inc. Date of Enforcement Report 8/1/2018 Class lI: PRODUCT CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000 Recall Number: Z-2522-2018 REASON Abbott is advising customers that a small number of CardioMEMS(R) Hospital Electronics Systems (Model CM3000) and Patient Electronics Systems...
Read More

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

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