Z-1972-2021Class I

Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use...

Name: Z-1972-2021 Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use...
Creator: Philips Respironics, Inc.
Published: 2021-06-14
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2021-06-14 / Open, Classified / root cause: design

FDA source

Philips Respironics, Inc. began a recall of Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19... on 2021-06-14. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1972-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-06-14
Posted: 2021-07-13
Recalling firm: 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.
Product code: MNS Ventilator, Continuous, Non-Life-Supporting
Reason for recall: 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 tag: design
FDA 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 in commerce: 15,357,775 (10,307,186 in US, 5,039,748 OUS) in total
Distribution: Global distribution
Product codes and lots: All Serial Numbers Material Numbers: DSX9999H11 INX9999H19 RINX9999H19

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1972-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1972-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-13
Z-1973-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-13
Z-1974-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-13

Product code MNS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)