Software Issue Could Cause Sudden Shutdowns For Some Bellavista Ventilators

No patient injuries have been reported due to the problem, which is now the subject of a voluntary field correction.

Vintage inscription made by old typewriter, warning

Some Bellavista ventilators from Vyaire Medical Incsubsidiary Imtmedical AG may suddenly shut down and issue a technical failure alarm due to a software issue, the US Food and Drug Administration announced on 4 February.

The company initiated a voluntary field correction to address the problem last December. No patient injuries have been reported.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Respiratory

CDX Medical Technologies Secures $2.5M To Advance Smart ECMO Platform Toward FDA Approval

 
• By 

CDX is eying applications for its pump platform that go beyond ECMO. The company’s CEO says smart pumps that can be fine-tuned to patient volume and configuration are needed, and CDX is creating a scalable solution capable of supporting both acute and chronic lung care.

Surgical Robotics CEOs Talk Metrics For Success, Valuations, Competition And IPO Outlook

 
• By 

Leaders of robotic systems companies Distalmotion, Neocis and Noah Medical discussed success metrics, competition and funding. Institutional investors are focusing on utilization, procedure rates and a clear path to profitability as the IPO window reopens, BTIG analyst Ryan Zimmerman said.

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By 

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.

More from Device Area

Bivacor Rotary Heart Could Upend The Artificial Heart Market, If It Reaches Its Destination

 
• By 

Bivacor aims to be first to the US market with a permanent total artificial heart, starting with use as a bridge to transplant. CMO William Cohn says data from countries with low transplant rates could support pivotal trials and long-term use.

Ochsner Surgeon In ‘The Big Easy’ Eases Patient’s Pain With Skill And Virtual Reality

 

A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.

FDA Commissioner’s Voucher Program Should Include Devices, Transplant Technology Firm Says

 
• By 

The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.