Z-1784-2022Class I

Therapy Mask 3100 NC/SP

Name: Z-1784-2022 Therapy Mask 3100 NC/SP
Creator: Philips Respironics, Inc.
Published: 2022-09-06
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2022-09-06 / Open, Classified / root cause: labeling and UDI

FDA source

Philips Respironics, Inc. began a recall of Therapy Mask 3100 NC/SP on 2022-09-06. FDA classified it as Class I and gives the reason as "No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1784-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-09-06
Posted: 2022-09-30
Recalling firm: Respironics, Inc.
Product: Therapy Mask 3100 NC/SP
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm started notifying customers of this recall event via telephone on 9/6/2022. Additionally, customers were mailed an URGENT Medical Device Correction Letter dated 9/9/2022 that communicates that the firm is updating the Contraindications and Warning language for the Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask, and Therapy Mask 3100 NC/SP due to the presence of magnets that may affect implanted medical devices and metallic splinters in the eye. All units of these masks are subject to this recall action. If a patient, a household member, caregiver, or bedpartner that is in close vicinity to patients using the mask is equipped with one of the medical devices or metallic splinters indicated in the updated Contraindications and Warning language, patients are to stop use of the affected mask and properly dispose of it once an alternative mask without magnets has been obtained after consultation with their healthcare provider. If the patient or others around them does not possess an implanted device or metal splinters included in the updated contraindications language, no action is needed. Users and those in the vicinity of the patient while using the mask must ensure the mask is kept at least six inches from medical implants and metallic splinters in the eye. Customers with any questions are to contact Philips Customer Care Solutions at 1-800-345-6443. The firm issued a press release on 9/6/22 and can be found at the following link: https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20220906-philips-respironics-alerts-customers-worldwide-of-updated-instructions-and-labeling-of-specific-sleep-therapy-masks-that-contain-magnetic-headgear-clips-due-to-potential-risk-of-serious-injury.html. A second Urgent Medical Device Correction Letter was sent to customers on 12/1/2022. Should DMEs, distributors, and prescribers decide to continue distributing masks and mask accessories with magnet
Quantity in commerce: 42,954 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming, & District of Columbia. The countries of Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Brunei Darussal, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Germany, Ghana, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, St. Pier, Miquel., Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Uruguay, Utd. Arab. Emir., Uzbekistan, & Zimbabwe.
Product codes and lots: All Units; Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048, 1145049, 1145050, 1145051, 1145052, 1145055, 1145056, 1145057, 1145058, 1145059, 1145060, 1145061, 1145062, 1145063, 1145064, 1145065, 1145066, 1145067, 1145068, 1145069, 1145070, 1145071, 1145072, 1145073, 1145074, 1145459, 1145460, 1145461, 1145462, 1145463, 1145464, 1145465, 1145466, 1145467, 1145478, 1145916, 1145917.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1784-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1780-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-09-30
Z-1781-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-09-30
Z-1782-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-09-30
Z-1783-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-09-30
Z-1784-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-09-30

Product code BZD

K210386Class IIMagneto Nasal MaskRespironics, Inc. / cleared 2021-07-12

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)