Precision and accuracy are two valuable pillars of judgement that are often overlooked by consumers. How well these two conditions are met can significantly impact the ruling presented by the FDA on any medical device, substance or product. If precision and accuracy are not met properly by a commonly used medical device, it can often lead to a misdiagnosis for patients, which can prove to be fatal. There have been many instances where the FDA has ordered a recall of medical devices due to its lack of precision and accuracy. On June 8th, 2017 a recall was initiated by the FDA on a 3D revascularization device produced by Penumbra inc. During the surgical implant of this device, there was a risk of the delivery wire breaking or separating during use. As a result, fractured pieces of the delivery wire could be left inside the patients brain. This led to many serious adverse health effects on the patients. This example showed that although the device precisely served its purpose, it wasn’t able to prove itself to be accurate. Although all case of precision and accuracy may not be this severe, this shows how imperative it is for all medical devices to follow their guidelines as best as possible.

reference: https://www.fda.gov/medicaldevices/safety/listofrecalls/ucm567913