Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 1/8/2026 Class: II PRODUCT: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 Recall Number: Z-0999-2026 REASON: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without...Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 1/8/2026 Class: II PRODUCT: LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 Recall Number: Z-0999-2026 REASON: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without...Read More
Struggling with cybersecurity planning, execution, and postmarket surveillance? Asking yourself, “what does FDA expect? If it is any consolation, most medical device manufacturers are right there with you! But we have noticed that many struggles likely could have been avoided. The good news is that cybersecurity is on your radar – likely that is why...Read More
… declares the table of contents for an article, subtitled Software problems are responsible for 20 recalls a month in IEEE’s Spectrum magazine December 2025 issue (the article is available without an IEEE account: https://spectrum.ieee.org/medical-device-recalls) The article includes several summary charts about U.S. Food and Drug Administration (FDA) medical device recall data back to 2005,...Read More
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