Senator To Philips CEO: Fork Over Info On Class I Recall Of Sleep, Ventilator Devices – Pronto

Calling the situation “untenable” and “unacceptable,” powerful US Sen. Richard Blumenthal has given Vitor Rocha two weeks to answer questions about Philips’ high-risk recall of certain BiPAP, CPAP, and other mechanical ventilator devices.

The System One CPAP machine, seen here with an Amara View mask, was one of the recalled devices.
The System One CPAP machine, seen here with an Amara View mask, was one of the recalled devices

Calling the situation “untenable” and “unacceptable,” a powerful US senator has given the CEO of Philips North America a deadline to hand over information about a recent high-risk class I recall of the company’s sleep and ventilator devices.

Royal Philips initiated the recall on 14 June because sound abatement foam used in certain bi-level positive airway pressure (BiPAP),...

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

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?

US FDA Unveils Plans To Consolidate Support Services

 

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.