According to the U.S. Food and Drug Administration documents, in an ordinary year over 2,500 medical device recalls are provided in the USA. Several of these remembers merely need inspecting the gadget for troubles, however others need the return or devastation of the gadget. As soon as determined, the FDA classifies the source of these remembers right into 40 classifications, plus a catchall of “various other”: scenarios that consist of classifying mix-ups, troubles with expiry days, and counterfeiting.
What’s revealed right here is the failure of the 5 most significant trouble classifications located amongst the 56,000 entrances in the FDA medical-recall data source, which extends back to 2002: gadget style, procedure control (suggesting a mistake in the gadget’s production procedure), nonconforming material/component (significance something does not satisfy necessary requirements), software program problems, and product packaging.
Software issues are damaged down right into 6 source, with software program style by far the most significant trouble. The various other 5 are, in order: modification control; software program style modifications; software program production or implementation troubles; software program style problems in the production procedure; and software program in the “usage atmosphere.” That last one consists of cybersecurity problems, or troubles with sustaining software program, such as a mobile phone application.
This post shows up in the December 2025 print concern as “Clinical Gadget Recalls.”
发布者：Stephen Cass，转转请注明出处：https://robotalks.cn/the-biggest-causes-of-medical-device-recalls/
