Reported Jul 21, 2021 · Ongoing
DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
- DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironics E30 ventilator is intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
- Lot codes and dates
- All Serial Numbers Material Numbers
446 of 446 codes
ARX900H15ARX900S15AUX900S15AUX900T15AUX900T15CBLX900H15BLX900S15BRX900S18CAX900H12CAX900S12CAX900T12CAX900T12CCAX900T12WDEX900H13DEX900S13DSX900H11DSX900H11CDSX900H11WDSX900S11DSX900T11DSX900T11CDSX900T11WEEX900H15EEX900S15ESX900H15ESX900S15EUX900H15EUX900H19EUX900S15EUX900S19FRX900H14FRX900S14FRX900S14WGBX900H15GBX900S15INX900H19INX900S19INX900T19ITX900H15ITX900S15JPX900S16LAX900H19LAX900S19LAX900T19NDX900H15NDX900S15PPX900S10RGBX900S15TRX900H15TRX900S15UAX900S15UCDSX900S11ZAX900H19ZAX900S19BRX900S18RDEX900S13RDEX900H13RGBX900H15TRX900H15RDSX900S11
- All Serial Numbers Material Numbers
- Amount recalled
- 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Stop using this product now
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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