Device product
Philips Respironics DreamWear Full Face Mask
Z-1781-2022
Product summary
- Event
- Event 90705
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 9,191,280 units
- Official record key
device-enforcement:Z-1781-2022
Official wording
Reason: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
Code information: All Units; Model No.: 1133344, 1133345, 1133370, 1133371, 1133372, 1133373, 1133375, 1133376, 1133377, 1133378, 1133380, 1133381, 1133382, 1133383, 1133385, 1133386, 1133387, 1133388, 1133390, 1133391, 1133392, 1133393, 1133395, 1133400, 1133401, 1133405, 1133406, 1133407, 1133408, 1133410, 1133411, 1133412, 1133413, 1133415, 1133416, 1133417, 1133418, 1133423, 1133424, 1133425, 1133427, 1133430, 1133431, 1133432, 1133433, 1133434, 1133435, 1133436, 1133438, 1133450, 1133454, 1135275, 1135276, 1135277, 1135278, 1135327, 1135388, 1135389, 1135390, 1137430, 1137431, 1137437, 1137438, 1137439, 1137440, 1140235, 1143130, 1144347, 1146593, 1146594, 1146595, 1146596, 1146597, 1148363, 1133375RTL, 1133376RTL, 1133377RTL, 1133378RTL, 1133430RTL, 1133431RTL, 1133432RTL, 1133433RTL.
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.
Derived failure modes
-
Unknown
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.