Company: Caption Health Date of Enforcement Report: 7/28/2021 Class II PRODUCT Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0) Recall Number: Z-2111-2021 REASON The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect...Read More

Company: Soft Computer Consultants, Inc. Date of Enforcement Report: 7/28/2021 Class II PRODUCT SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in...Read More

Company: Respironics California, LLC Date of Enforcement Report: 7/28/2021 Class I PRODUCT Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory...Read More

This July 2021 Standards Navigator Report content is only available to Standards Navigator subscribers. See our Subscribe page for information on subscriptions. SoftwareCPR® Standards Navigator provides information and tools related to standards that play a significant role in health software and software intensive medical devices.  In addition to information on existing standards, our report keeps you...Read More