Skip to main content

FDA: CPAP Machines May Not Deliver The Right Treatment

FDA: CPAP Machines May Not Deliver The Right Treatment

FDA: CPAP Machines May Not Deliver The Right Treatment

Introduction

More than 1,000 apparently fixed Philips DreamStation CPAP and BiPAP machines are being recalled owing to a serial number mismatch, which may cause the equipment to fail to deliver sufficient breathing support to users.

The Philips DreamStation recall was notified by the US Food and Drug Administration (FDA) warning that repaired CPAP and BiPAP devices may fail to provide the right prescription or default to factory settings. They may also fail to administer therapy completely, offering major hazards to people who rely on sleep apnea equipment.

Philips issued the recall after receiving 43 complaints about difficulties with repaired DreamStation CPAP and BiPAP equipment. According to the manufacturer, no injuries or fatalities have been attributed to the recall.

The devices, which were previously subject to a massive Philips CPAP recall in June 2021 and then refurbished and returned to users, may have been allocated erroneous or duplicate serial numbers during programming, according to the recall notice. This issue may cause the device to use the incorrect prescription settings or to default to factory settings. In certain situations, they may completely fail to provide treatment.

According to the recall, there is no warning or indication that the devices are not functioning properly, and failure to provide treatment might result in respiratory failure, heart failure, significant injury, or death. As a result, the FDA has classified the recall as Class I, indicating that the agency believes the condition might cause serious harm or death.

Comments

Restricted HTML

  • Allowed HTML tags: <a href hreflang> <em> <strong> <cite> <blockquote cite> <code> <ul type> <ol start type> <li> <dl> <dt> <dd> <h2 id> <h3 id> <h4 id> <h5 id> <h6 id>
  • Lines and paragraphs break automatically.
  • Web page addresses and email addresses turn into links automatically.

Latest News

Study Finds Toxic Metals in E-Cigs and U-Cigs Vapors

Categories: E-Cigarette: JUUL

As health concerns about e-cigarette use escalate, emerging research suggests that a newer class of vaping products—ultrasonic cigarettes or u-cigarettes—may pose even greater risks.

A study published in Environmental Health Perspectives in…

Appeals Court Upholds $611M Roundup Verdict

Categories: Roundup

A Missouri appeals court has upheld a massive Roundup verdict originally totaling $1.5 billion, but significantly reduced the final amount Bayer and its Monsanto unit must pay to $611 million.

The case involved three plaintiffs from New…

Valsartan “Wave 2” Bellwether Trial Schedule Set by Court

Categories: Valsartan

As the first Valsartan bellwether trial approaches in September 2025, the federal judge overseeing the multidistrict litigation (MDL) is preparing a second set of trials.

This move comes in anticipation of the possibility that parties may…

✍️ FREE—3000 Pages Medical Record Review Trial!                
No Contract. No Risk—Fully Customized, Free!

Only 10 Firms Accepted—Offer Ends June 30!