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Philips Respironics CPAP, BiPAP and Ventilator Device Recall


 

Philips Respironics CPAP, BiPAP and Ventilator Device Recall

On June 14, 2021, Synaptrx Sleep was notified by Philips Respironics of the recall of certain models of their CPAP and BiPAP machines.

According to Philips Respironics, under certain conditions the sound-reducing foam within the recalled machines can emit small particles and volatile (gaseous) organic compounds. Deterioration of this foam occurred in a very small number (0.03%) of Philips Respironics’ machines sold in 2020, and has been attributed to the following situations:

  • when exposed to weather conditions of high heat and humidity
  • with use of ozone generating products such as SoClean™ machines
  • or due to age of the CPAP or BiPAP machine

Other manufacturers (such as ResMed) are not involved in this recall.

We strongly urge you to visit the Philips website to see if your model of Respironics machine has been recalled. The link below takes you to the Philips website page which includes instructions on registering your machine for the recall, as well as pictures and names of the models involved:

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

If you have additional questions, please contact the Philips claims processing and support center at 1-877-907-7508.

If you have a serious medical condition (such as severe COPD, heart disease, atrial fibrillation, or a history of stroke), or if you use an advanced model including Trilogy, AutoSV (ASV), AVAPS, AVAPS AE, BiPAP or BiPAP ST DO NOT STOP USING YOUR MACHINE. Continue using the machine even if it has been recalled. If you have further questions, please schedule an appointment to discuss with your provider.

If you have mild to moderate sleep apnea and use a CPAP or Auto CPAP machine that has been recalled, you should consider the recall and stop using the machine at your discretion. If you choose to discontinue use of your recalled machine, we suggest that you:

  • do not sleep on your back and place a pillow behind your back to prevent you from rolling over.
  • avoid alcohol, sedatives, or narcotics near bedtime.
  • discuss alternatives like adjustable oral appliances, oxygen or surgery at your next appointment.

If you choose to continue using a CPAP or BiPAP machine on the recall list, stop using ozone cleaning products such as SoClean ™. Do not subject your machine to environments with high heat or humidity, and if possible, keep the machine in an air-conditioned area (do not store the machine in your car).

Philips Respironics reports a nationwide shortage of microchips, resulting in the delay of CPAP and BiPAP manufacturing throughout the industry. Therefore, Synaptrx is unable to replace or dispense new models of these machines at this time.

Please note that only Philips Respironics can provide information on how to return your affected machine. Please visit their website or call the phone number listed above. 

 

**FDA has not approved a repair but are planning on shipping out new machines for people that have registered their machines. There is no timeline for this.

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