Philips Respironics, Inc.: Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 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.

Recall number

Z-1972-2021

Recalling firm

Philips Respironics, Inc.

Product

Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19 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.

Status

Open, Classified

Initiated

2021-06-14

Posted

2021-07-13

Terminated

not on file

Reason

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.

Root cause

Device Design

Action

Urgent Medical Device Recall notification letters were sent to customers beginning on 6/14/21. Immediate Actions to be taken by You, the User: 1. Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. 2. Register your device on the recall website www.philips.com/src-updates Call 1-877-907-7508 if you cannot visit the website or do not have internet access. An updated URGENT: Medical Device Recall notification letter was issued on 11/16/21. Immediate Actions to be taken by You, the User: 1. Talk to your health care provider to decide on a suitable treatment for your condition, which may include: a. Stopping use of your device b. Continuing to use your affected device, if your hcpr determines that the benefits outweigh the risks identified in the recall notification. c. Using another similar device that is not part of the recall or using alternative treatments for sleep apnea. 2. Follow the manufacturers instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Ozone cleaners may exacerbate the breakdown of the foam, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories. 3. Report any problems with a device through the FDA MedWatch Voluntary Reporting Form. 4. Register your device on the recall website www.philips.com/src-update with your device Serial Number. c. Call 1-877-907-7508 if you cannot visit the website or do not have internet access. Devices should be serviced only by qualified technicians. They do not include user serviceable parts. Attempts to remove the sound abatement foam may render the device permanently inoperative. Devices damaged due to attempts by the user to remove the sound abatement foam will not be able to be remediated.

Quantity

15,357,775 (10,307,186 in US, 5,039,748 OUS) in total

Distribution

Global distribution

Lot, serial or model codes

All Serial Numbers  Material Numbers: DSX9999H11 INX9999H19 RINX9999H19

510(k) numbers

not on file

PMA numbers

not on file

Product code

MNS

Firm FEI

2518422

Firm city

Murrysville

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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