Philips Admits New Issues In Reworked Ventilators

A silicone foam that replaced hazardous polyurethane in some reworked Philips Trilogy ventilators could separate from the unit and block air flow; additionally, particles have been found in ventilator air pathways. 

Philips company logo sign. Philips s a Dutch technology company headquartered in Amsterdam with focused in the areas of electronics, health care and lighting. Copenhagen, Denmark, August 22, 2017. - Image

Philips Trilogy ventilators that were reworked as part of a June 2021 recall may have new issues, the US Food and Drug Administration announced on 17 November.

The ventilators were initially recalled because the polyurethane foam used in them could degrade during use, potentially releasing particles...

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 Recalls

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.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

More from Policy & Regulation

MHRA’s Tallon Hails PMS Regulation As Start Of UK Device Framework Transformation

 
• By 

16 June marked the first major new regulatory instrument in the UK’s post-Brexit transition to a standalone device regulatory system for Great Britain.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By 

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?