FDA says Philips ventilator recall produced over 21,000 device reports, 124 deaths

The FDA updated its communications on Philips‘ (NYSE:PHG) major ventilator recall with new data on device reports and patient deaths.

In June 2021, Philips Respironics recalled millions of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

According to the FDA’s notice, the agency received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the PE-PUR foam breakdown or suspected foam breakdown in Philips Respironics’ ventilator devices between April 2021 and April 30, 2022.

Within the MDRs received by FDA — both mandatory reports from Philips and voluntary reports from health…

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FDA clears Philips’ MR 7700 imaging system

[Image from Philips]Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its new MR 7700 3.0T MR imaging system.

Amsterdam-based Philips designed the MR 7700 system to provide high accuracy to support clinical diagnostics through high-quality diffusion imaging and advanced neuroscience.

The company said in a news release that MR 7700 expands scanning capabilities with a fully integrated multi-nuclei imaging and spectroscopy solution for exploring new clinical pathways without sacrificing clinical imaging workflow or wide-bore patient comfort.

Philips’ MR 7700 has an easy-to-use interface that allows scientists and clinicians to access the scanner without compromising workflow, offering radiologists a way to image six different clinically relevant nuclei across all anatomies. The platform’s AI-driven smart connected imaging increases diagnostic confidence and adds important metabolic information to MR exams.

The com…

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The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

[Illustration via Adobe Stock] Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare.

The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients.

Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD).

Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon (Nasdaq: AMZN), Microsoft (Nasdaq: MSFT) and Google (Nasdaq: GOOGL).…

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The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

[Illustration via Adobe Stock]

Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare.

The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients.

Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD).

Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon (Nasda…

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May 2022 Issue: The cloud is transforming medtech

 

The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

How DeepWell is developing video games as tools for treating medical conditions

Digital therapeutics open up new opportunities in medicine

Harnessing the power of cloud computing

When Johnson & Johnson and Microsoft announced a deal earlier this year to use cloud computing to support digital surgery, executives on both sides spoke with Medical Design & Outsourcing about how the partnership could advance medtech.

That started a series of conversations with leaders at cloud computing giants Google, Microsoft and Amazon — and on the device side at Johnson & Johnson, Philips and GE Healthcare. We consistently heard that the COVID-19 pandemic accelerated cloud adoption not only for medical records and telehealth, but also for manufacturing operations, supply chain management and making new vaccines, therapies and d…

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FDA may order Philips to resolve respiratory devices recall

The FDA has proposed an order requiring Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices.

FDA’s proposal regards the June 2021 recall of millions of certain Philips ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

Get the full story at our sister site, MassDevice.

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FDA may order Philips to resolve respiratory devices recall

The FDA proposed that an order should be issued to require Philips (NYSE:PHG) to submit a plan for its recalled respiratory devices.

FDA’s proposal regards the June 2021 recall of certain ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines due to potential health risks caused by polyester-based polyurethane (PE-PUR) sound abatement foam breaking down. Foam particles could enter a device’s air pathway, causing a range of potential health problems and toxic, carcinogenic effects for the user.

Amsterdam-based Philips said last summer that it was no longer taking orders of sleep therapy systems as it handled the Class I recall, which knocked it out of the sleep therapy market for at least a year. In March, the FDA issued a notification order alerting Philips that its notification efforts on the recall of its ventilators have been inadequate to date.

Last week, the company disclosed a Department…

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DOJ subpoenas Philips over Respironics recall; CEO addresses investigation

Royal Philips CEO Frans van Houten [Photo courtesy of Philips]Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpoena for information related to the massive recall of Respironics respiratory devices.

Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial and operating results. Phillips said its subsidiaries are cooperating with investigators.

“At this time, it’s a subpoena for information,” CEO Frans van Houten said on today’s earnings call. “That means they are preparing an investigation, and we just have to accept that.”

Philips shares dropped about 12% in trading Monday as the company detailed continued supply chain struggles and mounting recall costs.

Van Houten said Phillips remains in close collaboration and contact with regulatory agencies.

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DOJ subpoenas Philips over Respironics recall; CEO addresses investigation

Royal Philips CEO Frans van Houten [Photo courtesy of Philips]

Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpeona for information related to the massive recall of Respironics respiratory devices.

Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial and operating results. Phillips said its subsidiaries are cooperating with investigators.

“At this time it’s a subpeoena for information,” CEO Frans van Houten said on today’s earnings call. “That means they are preparing an investigation and we just have to accept that.”

Philips shares dropped about 12% in trading Monday as the company detailed continued supply chain struggles and mounting recall costs.<…

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Philips shares take a dive as supply chain issues, ventilator recalls impact Q1 results

Royal Philips (NYSE:PHG) shares took a hit today on first-quarter results that felt the effects of ongoing issues with supply chain and recalls.

PHG shares were down 12.1% at $26.67 in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was virtually even on the day.

The Amsterdam-based company posted losses of $161.8 million (€151 million), or 18¢ (€0.17) per share, on sales of $4.2 billion (€3.9 billion) for the three months ended March 31, 2022, for a bottom-line slide into the red on sales growth of 2.4%.

Adjusted to exclude one-time items, earnings per share came in at 16¢ (€0.15).

Philips CEO Frans van Houten said in a news release that the company’s results came in “challenging circumstances” with significant supply chain headwinds and the consequences of its ongoing issues with ventilator recalls.

Additionally, van Houten said th…

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Philips says CavaClear used successfully for IVC filter removal

Royal Philips (NYSE:PHG) announced today that the first patients were successfully treated with its CavaClear IVC filter removal laser sheath.

Patients were treated for inferior vena cava (IVC) filter removal using CavaClear at Northwestern Medicine (Chicago) by Dr. Kush R. Desai and at Stanford Hospital (Palo Alto, California) by Dr. William T. Kuo.

Amsterdam-based Philips designed CavaClear for patients who have an IVC (inferior vena cava) filter inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs. The new device — first laser-based device for removing IVC filters — removes tissue to facilitate the detachment of an IVC filter during retrieval when previous removal methods have failed.

Philips garnered FDA authorization for CavaClear in December 2021 through the de novo pathway, with the device receiving FDA breakthrough device designation.

Desai said in a news release that millions of pa…

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Philips has another round of serious ventilator recalls

Royal Philips’ (NYSE:PHG) ventilator problems continue as the company has issued further recalls for its respiratory devices.

The Amsterdam-based company earlier this week issued FDA Class I recalls — the most serious kind — for all models of the Philips Respironics V60 ventilator, the V60 Plus ventilator and the V680 ventilator (distributed outside the U.S.).

For all three ventilators, an issue has been identified surrounding an internal electrical circuit within the devices. In some cases, the issue impacting the circuit could potentially result in the ventilator ceasing to operate. At least 99,283 devices are affected, with no total device number listed for the V680. The company projects an average of less than one silent shutdown with the affected devices among one million uses per year, according to a spokesperson.

Philips is not advising customers to remove the affected ventilators from service as they may continue to be used in accordance wi…

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