When a software patch or device update cannot remedy a cyber threat, sometimes a recall is necessary.
Experts at hospitals state that they need clearer and more organized information from device manufacturers during a recall.
Recalls involving lithium-ion battery components are far more complex and if not handled properly, can have dangerous consequences.
The center is changing its communication on recalls to minimize confusion among healthcare providers and patients.
Having a comprehensive plan in place and conducting mock recalls can help a device company protect its brand before it’s too late.
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This week’s offender was awarded nine Form 483 observations.
An upcoming conference brings together FDA and key industry stakeholders to discuss best practices in health hazard evaluations and global recalls.
Almost half as many devices were recalled this year compared to 2014.
Discussing device problems can have a serious affect on patients. Physicians, manufacturers, and FDA should clarify their message to maintain trust.