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Surgical Navigation Application Defect Highlights Software Recalls

spine-CT-scanThe Brainlab, Spine & Trauma 3D 2.0 Navigation Software manufactured by Brainlab AG is being recalled due to faults with programming.

Product recalls have taken place for well over a century, but most involve physical products. This latest revelation is part of a new generation of recalls – those affecting software.

The Brainlab AG application allows healthcare workers to create 3D maps of the inside of a human body, reducing the need for surgical examinations. During surgeries, the software allows doctors to precisely monitor the position and orientation of instruments, making operations less invasive, improving patient recovery time.

The FDA has released a list of guidelines operators should adhere to until an updated version of the software is available. Nationwide, there are more than 130 locations using the medical device application.

Brainlab is not alone in producing products with faulty software. In February, Toyota was forced to issue a recall on all new Prius automobiles. A total of 1.9 million vehicles had been manufactured with a glitch in programming that occasionally caused motors to shutdown, going into failsafe mode. Prius owners were asked to return their car to a dealer for a software update that took about 40 minutes to complete.

Nissan has its own challenges lately, issuing a recall of almost a million vehicles due to a defect in software controlling airbags.

Mazda recalled Mazda 6 cars manufactured between 2010 and 2012, because the vehicles attracted spiders. Their solution was a software update, warning drivers of arachnids in the engine.

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