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What You Need to Know About the Philips Respironics Recall

What You Need to Know About the Philips Respironics Recall

Philips Respironics has issued a recall for several of their key product lines of respiratory and sleep therapy equipment. This recall impacts products manufactured before April 26, 2021 in three key categories:  

  • Continuous ventilators 
  • BiPAP devices 
  • CPAP devices 

Life Tech customers may be impacted by this product recall. Below, you can find all the information you need about the reason for the recall, which products are being recalled, and what you should do if your product is on the recall list. If you have any questions, please contact us.  

Reason for Philips Respironics Recall 

Philips Respironics issued a voluntary recall for those products for two issues related to a polyester-based polyurethane (PE-PUR) foam. The issues include:  

  1. The PE-PUR foam will degrade over time into particles that can break away and enter the device's air pathway. 
  2. The PE-PUR foam may off-gas certain chemicals, which may be accelerated by certain chemical cleaners, including Ozone. 

Once the PE-PUR foam enters the devices air pathway, it can enter your airway and has the potential to cause the following health problems: 

  • Irritation (skin, eye, and respiratory tract) 
  • Inflammatory response 
  • Headache 
  • Asthma 
  • Adverse effects to other organs (e.g. kidneys and liver) 
  • Toxic carcinogenic affects 

The potential risks of the chemical exposure include:  

  • Headache/dizziness 
  • Irritation (eyes, nose, respiratory tract, skin)  
  • Hypersensitivity 
  • Nausea/vomiting 
  • Toxic and carcinogenic effects 

Philips Respironics Devices Being Recalled 

The recall affects all devices and all serial numbers manufactured before April 26, 2021. Some products being recalled include the DreamStation ASV, SystemOne ASV4, and the Trilogy 100 ventilator series. Go to the Philips website to see the full list of the recalled items

What To Do If Your Product Is On the Recall List 

Philips recommends the following actions if your product is on the recall list: 

  • For patients using BiLevel PAP and CPAP devices:  
  • Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.  
  • For patients using life-sustaining mechanical ventilator devices:  
  • DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps. 

 
Philips is recommending that customers and patients do not use ozone-related cleaning products. Additionally, Philips is reminding customers and patients to review the age of their BiLevel PAP and CPAP devices, as they are recommended to be replaced after five years of use. 

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