Philips issued a recall notification deemed Class I — the most serious kind — for its BrightView SPECT imaging systems. In December 2023, Philips notified customers about a potential issue with BrightView systems (including BrightView, BrightView X and BrightView XCT). Under specific circumstances, the detector may move downward due to a potential component (lead screw) […]
Philips
FDA clears latest Philips TEE transducer for cardiac care
Philips announced today that the FDA granted 510(k) clearance to its latest TEE transducer technology. The Dutch medtech giant designed its transesophageal echocardiography (TEE) ultrasound transducer to help in the early diagnosis of structural heart disease. TEE helps cardiologists by providing highly detailed images of the heart and its internal structures. Additionally, TEE can help […]
Philips discontinues certain CPAP product lines after recall saga, stock sinks on Q4 results
Philips has discontinued the U.S. sales of several respiratory device product lines, including one from its much-maligned CPAP portfolio. The company says it agreed with the FDA and the DOJ on the terms of a consent decree focused on the Respironics business. Philips says it provides “clarity and a roadmap” for compliance and the restoration […]
How Philips’ significant respiratory devices recall unfolded
There are 5.5 million recalled CPAPs and other devices — and reports of deaths. Here’s a Philips recall timeline. Philips in mid-2021 kicked off a recall that involved millions of CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — had sound abatement foam that could […]
Report: Concerning chemicals found in replacement Philips CPAPs
Replacement machines issued by Philips amid its respiratory device recall may have more issues, according to ProPublica and the Pittsburgh Post-Gazette. Philips Respironics has recalled more than 5 million devices since 2021 due to dangerous degradation of sound abatement foam. The FDA has received more than 100,000 reports of problems related to the recall, including at […]
Philips recalls MRI system due to risk of exploding
The FDA says a recall of Philips Panorama 1.0T HFO magnetic resonance imaging (MRI) systems is Class I, the most serious kind. Philips recalled the MRI system due to a risk of explosion during a quench procedure. The excessive pressure buildup of helium gas could cause this. To date, Philips has received reports of one […]
The top medtech trends of 2023
The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods. With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more. Here are the top stories […]
Philips’ BioTelemetry to pay $14.7M to settle false claims violation allegations
Philips’ BioTelemetry and its LifeWatch subsidiary agreed to pay more than $14.7 million over False Claims Act violation allegations. Philips acquired BioTelemetry in a $2.8 billion deal in 2021. The BioTelemetry subsidiary settled allegations of knowingly submitting claims to federal healthcare programs for a higher level of remote cardiac monitoring than physicians intended to order, […]
U.S. senators call for review of FDA following Philips recall fallout
Two U.S. senators sent a letter calling on the government to review the FDA’s oversight of medical device recalls amid the ongoing Philips Respironics recall. Majority Whip Dick Durbin (D-IL) and Sen. Richard Blumenthal (D-CT) sent the letter to the Government Accountability Office (GAO). The letter requests an update to a 2011 GAO report entitled […]
FDA warns of thermal issues with Philips DreamStation 2 CPAP machines
The FDA is warning patients and health care providers to watch Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The medical device safety agency said it recently received an influx of medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while […]
Philips unveils next-gen ultrasound systems
Philips today highlighted the capabilities its next-generation EPIQ Elite and Affinity ultrasound systems. The new systems feature automated tools and a common user interface with transducer compatibility across Philips ultrasound systems. That includes the recently introduced Compact Ultrasound 5000 Series. Amsterdam-based Philips says its latest advances demonstrate a positive impact on patient and staff satisfaction. […]