Philips' CPAP Recall Updates and Solutions (as of 8/23/2021)

 All Horne Insurance Agency clients take note that as of 8/23/21, Philips Respironics announced a voluntary recall notification due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in their CPAP and BiPAP machines.

1. Sound abatement foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and
2. the sound abatement foam may off-gas certain chemicals.

UPDATE**

Philips predicts it takes approximately 12 months to complete the recall worldwide. Although the repairs/replacements are on hold until FDA approves their new foam design, Philips are making 55,000 repair kit per week in Q3 2021, and aim to 80,000 per week in Q4 2021. Once FDA gives the green light, Philips can start repair/replacement asap.

on 8/20, Philips is replacing the DreamStation CPAPs at all US merchants with the new DreamStation 2 (DS2) machines. The old DreamStation CPAPs are in the recall list while the DS2 is not. Upon the recall, all US merchants immediately ceased shipments of DreamStation machines to patients. There are many recalled machines left in merchants inventory. Philips is replacing them with the DS2, which is not impacted by the recall defects. Many merchants have the DS2 in stock and available for sale. We expect the shortage will ease in the next two months but won't go back to normal - thanks to COVID-19: 1) the global shortage on the micro chips slows down the CPAP production; 2) The ocean shipping is delayed due to lack of containers and US ports backlog.

8/17/2021: Philips is sending (probably) 20,000-30,000 registered USPS mails to impacted customers, if the original medical store purchased the machines from Philips decided to let Philips notify patients that their units are under recall. The mails are not to initiate the repair or replacement process. All the information in the mail can be found in Philips official website. Please pay attention to your USPS mailbox (not email!). Note: if you purchased machines from Respshop you won't receive these USPS mails as we chose to notify our patients via emails which is much faster way.

8/17/2021, Philips is still waiting for FDA’s approval for the new foam. Philips has tripled their production power of this new foam and is waiting for a green light from the FDA. Philips has not given us the replacement schedule yet. We don't have any information on which machines will be replaced and which ones will be repaired.

 

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