Z-1783-2022 Class I Ongoing
FDA device recall Z-1783-2022 was initiated by Philips Respironics, Inc. on Sep 6, 2022 and is designated Class I. Reason for recall: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. The recall status is ongoing. Affected quantity: 6,237,558 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 12, 2022
- Initiation Date
- Sep 6, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,237,558 units
Product Description
Reason for Recall
Distribution Pattern
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1783-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026