MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Zimmer Biomet warns on isocentric movement issues in Rosa platforms

Zimmer Biomet warns on isocentric movement issues in Rosa platforms

By

Zimmer Biomet

Zimmer Biomet (NYSE:ZBH) today issued a voluntary medical device field action for its Rosa Brain, Rosa Spine and Rosa One surgical robotic platforms over movement issues with the systems’ robotic arms.

The company said that a situation can occur where the robot arm’s position is automatically sent to the trajectory input due to an imperfect mathematical model that could prevent the arm from reaching its desired position.

If the error occurs during isocentric micromoves used in brain surgeries while instrumentation is already in place inside the patient’s anatomy, the company warned that a hazardous situation could occur. Possible results could be ineffective treatment, serious injury or even death, according to an urgent medical device notice.

During other procedures, the company warned that the issue could lead to a displayed error on the system and a delay in surgery.

No customer reports of the issue have been received, according to the company.

Warsaw, Ind.-based Zimmer Biomet instructed any users to discontinue the use of micromovement functions in iso centric mode during brain surgeries with its Rosa Brain 3.0 and Rosa one devices.

The company said that it is preparing a software patch to correct the issue, with a slated release date of August 2017.

Zimmer Biomet picked up the Rosa platform when it paid approximately $132 million to acquire its original developer, French robot-assisted surgery firm Medtech, last July.

In case you missed it

RSS From Medical Design & Outsourcing

  • Respira Labs seeks FDA clearance for its wearable lung monitor
    Respira Labs recently announced that it has developed a wearable device that continuously assesses lung function without the need for traditional pulmonary function tests. Mountain View, California-based Respira Labs designed its Sylvee wearable initially to assess chronic obstructive pulmonary disease, COVID-19 and asthma patients. It is embedded with speakers and microphones that measure the change… […]
  • Owen Mumford starts work on new production center in U.K.
    Owen Mumford this week announced that it has started building its new production facility in Witney, Oxfordshire in the U.K. Owen Mumford’s new Witney facility will stand as a production site for the company’s recently launched, next-generation auto-injector Aidaptus. The company has decades of experience creating its own drug delivery, blood sampling and rapid diagnostic… […]
  • FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron
    Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy. In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests,… […]
  • Traco Power launches THM 60WI DC-DC converters
    Traco Power today announced it has launched its THM 60WI series of quarter brick DC-DC converters. The Baar, Switzerlad-based company designed the DC-DC converters with ultra-wide input ranges and safety approvals for medical and industrial applications. Traco Power’s THM 60WI series of converters consists of 12 models with 9-75 or 18-75 Vin ranges with single… […]
  • The 10 largest medtech employers of 2021 – and what their employees really think
    Employees of the 10 largest medtech employers are proud of working on life-saving products — with a greater appreciation for diversity and inclusion initiatives. That was one major takeaway as Medical Design & Outsourcing compiled some current and former employee reviews posted on Glassdoor. (Browse the online version of our Big 100 report.) Despite the pride, there was… […]
  • COVID-19 test makers say their products also detect Omicron
    Abbott, BD, Hologic, PerkinElmer, Thermo Fisher and Quidel are reassuring the public that their COVID-19 tests detect the Omicron variant. Discovered last week in South Africa, the new variant has enough mutations that it has raised concerns worldwide — even though it is still unknown for sure whether the mutations cause greater transmissibility or vaccine… […]
  • November 2021 Issue: The Big 100 – Medtech’s 100 Largest Players
      Browse the online version of the Big 100 An even larger medtech supply chain shock looms beyond the pandemic European approval ‘a big deal’ as Medtronic moves forward with Hugo surgical robot How medtech fared in the first waves of the pandemic People move the medtech industry forward The term “supply chain” brings to… […]
  • Could winged microchips monitor for airborne disease?
    Northwestern University engineers have created what they claim are the smallest-ever human-made flying structures — winged microchips that could monitor the air for disease and pollution. Engineering professor John Rogers and his team at Northwestern drew on inspiration from nature to create the microchips, which are the size of a grain of sand. The chips… […]
  • Smith+Nephew expands reach of its Cori handheld robotic system
    A year after Smith+Nephew (NYSE:SNN) launched its Cori handheld robotic system in the U.S.,  the ortho surgery system has launched globally. The British medtech giant has expanded Cori’s reach to Europe, Australia and New Zealand, India, and Canada (just announced today). The company yesterday said the system was now available for use in the U.K.’s National Health… […]
  • Elizabeth Holmes reportedly expresses remorse in criminal fraud trial
    Elizabeth Holmes reportedly revealed some regret over her handling of business as the ex-Theranos CEO took the stand again in a criminal fraud trial. Taking the stand yesterday for the third day of testimony in federal court in San Jose, California, Holmes was said to have shown remorse while still shifting some of the blame… […]
  • Supply chain, manufacturing issues slow Medtronic’s Hugo launch, ramp-up expected next fiscal year
    Medtronic (NYSE:MDT) Chair & CEO Geoff Martha confirmed that the launch of the Hugo surgical robot platform is off-schedule. Hugo received CE mark approval last month. The company is gearing up to conduct its FDA investigational device exemption (IDE) clinical trials in the U.S., with more on its stateside efforts still to come, Medtronic’s surgical robotics… […]