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October 27, 2021
Company: Philips Ultrasound Inc Date of Enforcement Report: 10/27/2021 Class II PRODUCT EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 Recall Number: Z-0123-2022 REASON Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided...
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Company: Canon Medical System, USA, INC. Date of Enforcement Report: 10/27/2021 Class II PRODUCT Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Recall Number: Z-0142-2022 REASON A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is...
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The Medical Device Innovation Consortium (MDIC) recently partnered with the MITRE Corporation, Adam Shostack, and the FDA to host a webinar regarding the soon to be released “Playbook for Threat Modeling Medical Devices.” The playbook was created during a series of bootcamps held by the team over the past year and the webinar provided a...
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The FDA CDRH announced the guidance documents they intend to publish in FY2022. They also announced their intention to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years of the close...
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