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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…

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.<…

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…

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…

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…

Philips-backed study says more could be done to treat cardiac device infections

Roughly four in five Americans with cardiac implantable electronic device infections don’t receive recommended treatment, according to a Philips-funded study out of Duke University.

The large-scale, real-world analysis of CMS data also found that complete hardware extraction within 6 days was associated with a 42.9% lower risk of death than among patients who did not undergo device removal. Groups including the Heart Rhythm Society (HRS) have recommended extraction for all patients with a definite CIED infection, including complete device and lead removal.

Duke University researchers unveiled the results at the American College of Cardiology’s 71st Annual Scientific Session, which is wrapping up today in Washington, D.C.

Get the full story on our sister site Medical Design & Outsourcing.

Philips-backed study says more could be done to treat cardiac device infections

Roughly four in five Americans with cardiac implantable electronic device infections don’t receive recommended treatment, according to a Philips-funded study out of Duke University.

The large-scale, real-world analysis of CMS data also found that complete hardware extraction within 6 days was associated with a 42.9% lower risk of death than among patients who did not undergo device removal. Groups including the Heart Rhythm Society (HRS) have recommended extraction for all patients with a definite CIED infection, including complete device and lead removal.

“This study highlights the life-threatening nature of device infections and the significant opportunities to improve care in these complex patients,” Dr. Jonathan Piccini, the lead investigator of the study and the director of Cardiac Electrophysiology section at the Duke Heart Center, said in a news release. “The findings also emphasize the importance of timely diagnosis and complete treatm…

Philips launches Ultrasound Workspace for improved echocardiography workflows

[Image from Philips]Royal Philips (NYSE:PHG) announced today that it launched the Ultrasound Workspace echocardiography image analysis and reporting platform.

Amsterdam-based Philips designed the Ultrasound Workspace system for clinicians to access it remotely via browser, allowing them to leverage diagnostic workflows from the ultrasound exam room to the reporting room and beyond to wherever echocardiography data needs to be reviewed and analyzed.

The company said in a news release that the Ultrasound Workspace provides a consistent set of on-and-off-cart, AI-driven image analysis and quantification tools, improving productivity and consistency while enhancing diagnostic quality. The platform leverages AI for speed and diagnostic confidence with the ability to analyze vendor-agnostic data.

Philips added that Ultrasound Workspace represents a holistic, scalable system for analysis and reporting and offers greater flexibility for adopting workflows based on …

Philips launches Azurion image-guided therapy system with Ambient Experience with FlexVision

[Image from Philips]Royal Philips (NYSE:PHG) announced today that it made its Azurion system with Ambient Experience with FlexVision commercially available.

Amsterdam-based Philips’ Ambient Experience with FlexVision display connects to the Azurion image-guided therapy system to offer patients a calming multi-sensory experience while the staff prepares them for their procedure, prior to the display then being used for the actual intervention.

According to a news release, Philips designed the technology to allow interventional team members to adapt to the room’s ambient lighting and sound to add to the overall feeling of calm, potentially improving both the patient and staff experience while leading to positive outcomes and enhanced workflows and productivity.

The company said that the solution could reduce the overall procedure time and in some cases reduce costs associated with patient sedation or general anesthesia by mitigating the clinical a…

Government warns on cybersecurity issues with Philips’ e-Alert MRI monitoring system

The U.S. Cyber Security & Infrastructure Security Agency (CISA) today issued a notice regarding the e-Alert system from Royal Philips (NYSE:PHG).

CISA called attention to the e-Alert MRI system monitoring platform (version 2.7 and prior) and a potential vulnerability related to “missing authentication for critical function.”

According to the CISA notice, successful exploitation of the vulnerability — in which the software does not perform any authentication for critical system functionality — could allow an unauthorized actor to remotely shut down the system if on the healthcare facility’s network.

Philips plans a new release to remediate the vulnerability before July 2022. For interim mitigation to the vulnerability, Philips recommends that users operate all Philips deployed and supported products within Philips authorized specifications, including physical and logical controls, with only authorized personnel permitted to access th…

Philips warns on software defect in some Azurion systems

Royal Philips (NYSE:PHG) issued an urgent field safety notice to warn on a software defect with its Azurion system.

The notice, issued last month in Europe, informed users of a problem that can occur when the user selects the “Add Study” function to add a new study to a patient when using the Azurion image-guided therapy platform.

In the software, the Add Study dialogue box is displayed where the patient type is selected to perform the study, but, due to a software defect, when the study is initiated by selecting “Start Procedure,” the patient type inadvertently changes to one different than the one selected.

A change in patient type could lead to image quality degradation (which would see the radiation dose at a level considered too low) or an additional X-ray dose for the patient (leading to higher radiation than required). No harm is expected from the additional radiation dose, according to the notice.

Philips has receiv…