Quote:"We have already reached the majority of affected customers and we will correct this issue via a repair (replacement of the foam) on site in the coming months" a company spokesperson said in an emailed statement to Reuters.  This is the latest recall by Philips to be labeled Class 1 after it pulled back up to 4 million breathing-aid machines last year amid concerns that a polyurethane foam used in the devices could degrade and become toxic.

Earlier this month, the company raised that estimate by 1 million.  
[https://www.reuters.com/business/philips-q4-earnings-hit-by-part-shortages-ventilator-recall-2022-01-12/]

A Philips supplier had incorrectly used a type of polyurethane foam, which is intended to reduce sound and vibration, in one of the parts of the Trilogy Evo ventilators - an issue that was identified during lab testing, the regulator said on Wednesday.  The supplier used polyester-based polyurethane foam instead of a polyether-based one which is specified for these products and meets all applicable standards, Philips said in the email.  The polyester-based foam could break down and potentially enter the device's air pathway, leading to the user inhaling chemicals or other harmful materials, the FDA said.

(01-27-2022, 08:03 PM)StratCat48 Wrote: Sora....  Registered my Dreamstation 1 on 7/1/2021. Received a Dreamstation 2 on 10/10/2021 and have been using since. If you're using the Dreamstation 1 as a BiPAP you will not get a Dreamstation 2, so the times may be different.

(01-27-2022, 08:10 PM)Dafod Wrote: Now that you can get a new casing through Amazon I am wondering how many people will decline to return their existing DS1s? 

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We’re writing to you with two important updates about your recalled Philips device.* As always, thank you for your continued patience as we work hard to ensure as many patients as possible can continue safely with their therapy. Our first update is to inform you of the initial test results around the possible emission from the sound abatement foam. Our second update is to let you know how we are planning to prioritize remediation around the needs of patients.

1. Test results of volatile organic compounds (VOCs)
   The testing program, which we have carried out together with independent clinical experts and certified laboratories, indicates that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences. If you do not use a first-generation DreamStation device, please be assured that we will update you as soon as we receive more results from the ongoing program.**  These findings support a better understanding of the long-term impact on health but do not change the current course of our recall.  Our most recently updated guidance for all patients can be viewed here; we are continuing the recall efforts as planned.
   
   

1. Order processing
   To make sure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the Food & Drug Administration.  For US patients whose remediation is directly managed by Philips, data collected throughout the patient registration process will be used to help to prioritize remediation of those patients at higher risk. In addition to this prioritization, the shipment of replacement devices happens as inventory is available, and Philips collects the information needed to transfer existing therapy settings to the replacement unit.
   

In the coming weeks, you will receive an email that outlines the option to provide additional prioritization information. The types of information you may provide include: your age; whether you have any other health conditions including obstructive sleep apnea (OSA) and its severity; whether you are pregnant or have an occupation associated with public safety; your history of car accidents related to falling asleep while driving; and whether you have used ozone for device cleaning purposes. 

We understand the period of uncertainty this creates and thank you for your patience. We will continue to provide regular updates to you through this process.

In the meantime, as a reminder, your device registration confirmation number is [redacted for privacy].  
Thank you for your continued trust.
 

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*Voluntary recall notification in the U.S. / field safety notice outside of the U.S.
**Additional testing and research is ongoing, including: Assessment of the health risks associated with VOC emission of the CPAP, BiPAP and Mechanical Ventilator devices affected by the recall notification; assessment of the health risks associated with possible degraded foam particulates for all affected devices; assessment of the health risks associated with exposure of the devices to repeated ozone cleaning.