Analysis Of Fda Recalls Of Software-Based Medical Devices

Software-Related Recalls of Health Information …

https://pubmed.ncbi.nlm.nih.gov/28895231/

Methods: Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall …

Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that …

Software as a Medical Device (SaMD) | FDA

https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd

2022 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls

2021 Medical Device Recalls Subscribe to Medical Device Safety and Recalls Sign up to receive email updates on medical device recalls, safety communications, and other …

Study of Software-Related Causes in the FDA Medical …

https://ieeexplore.ieee.org/document/8292803

In this paper, we first present a process that collects software-related medical device recalls from the FDA database. Collecting all software-related medical device …

2023 Medical Device Recalls | FDA

https://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls

An official website of the United States government Here’s how you know U.S. Food and Drug Administration Search Menu Home Medical Devices Medical Device …

Artificial Intelligence and Machine Learning (AI/ML) …

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices

Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed (via 510 (k) clearance, granted De Novo request, or …

118. An Analysis of Medical Device …

https://www.boisestate.edu/undergraduate-research/2020/04/22/118-an-analysis-of-medical-device-recalls/

A recent study examined cybersecurity attacks in medical devices, then characterized the vulnerabilities based on reports from the CVE and ICS-CERT databases (3). This analysis …

Medical Devices Recalls Analysis Focusing on Software …

https://link.springer.com/chapter/10.1007/978-3-319-00846-2_291

Furthermore, classifications of the MD recalls according to reasons of failure and the level of health hazard have been performed. The results reveal that almost half of the medical …

Research : User Interface Software Errors in Medical …

https://pubmed.ncbi.nlm.nih.gov/31162965/

Based on information from the Food and Drug Administration's public and internal recall databases, 423 (~140/year) medical device recalls were identified as resulting from UI …