MetaMedical™ Solutions Inc

FDA issues Class I recall over Medtronic brain surgery software

The US Food and Drug Administration (FDA) has issued a Class I recall for a piece of Medtronic software used in locating anatomical structures during brain surgeries after it was found to display faulty text that  potentially misleads surgeons.

The Class I recall, the most serious type of recall, was issued for four separate versions of Medtronic’s StealthStation S8 application, designed to be used with a surgical drill, after customer complaints about a software error causing numbers or letters to be missing from the displayed text and replaced by a space. This could cause the surgeon to use an incorrect measurement for placement of the biopsy tip stop during navigation in neurosurgery.

The FDA states  that performing a cranial procedure using incorrect placement could lead to serious permanent injuries, including brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or death.

Medtronic added that they have  received 28 reports related to the issue with no injuries or deaths caused because of the error. The company has now issued an Urgent Medical Device Correction letter, stating that they are working on a free update to the software designed to address the specific issue. The affected software versions are versions 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1.

It follows almost a year after Medtronic’s previous Class I recall for some of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) due to a lack of energy being emitted from the devices.

Elsewhere in FDA recalls, OptumHealth has similarly been hit with a Class I recall over its infusion system designed to deliver medications or fluids to a patient via subcutaneous, intravenous, or perineural and epidural administration.

Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free
sample

Your download email will arrive shortly

We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form

By GlobalData







Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.


Source link