Philips Respironics, Inc. Recall 90705
Description: DreamWisp Nasal Mask with Over the Nose Cushion
Philips Respironics, Inc. Recall 90705 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1782-2022 |
| Event ID | 90705 |
| Event Description | DreamWisp Nasal Mask with Over the Nose Cushion |
| Product Type | Devices |
| 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. |
| Quantity | 930,813 units |
| Recall Reason | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. |
| Device Classification | 20221012 |
| Device Code Info | All Units; Model No.: 1137916, 1137918, 1137921, 1137922, 1137923, 1137924, 1137925, 1137926, 1137927, 1137928, 1137929, 1137930, 1137931, 1137932, 1137933, 1137934, 1137935, 1137936, 1137937, 1137938, 1137939, 1137940, 1137941, 1137942, 1137943, 1137944, 1137945, 1137946, 1137947, 1137948, 1137949, 1137950, 1137951, 1137953, 1137954, 1137955, 1137964, 1137965, 1137966, 1139332, 1139333, 1139334, 1139335, 1139336, 1144344, 1144345, 1144346, 1144502, 1148409, 1148410, 1148411, 1148913, 1148914, 1148915, 1148916, 1148917, 1137916RTL, 1137942AP, 1137942CE, 1137942RC, 1137943AP, 1137943CE, 1137943RC, 1137944AP, 1137944CE, 1137944RC, 1137945AP, 1137945CE, 1137945RC, 1137946AP, 1137946CE, 1137946RC. |
| Center Classification Date | 20220930 |
| Recall Initiation Date | 20220906 |
| Recalling Firm | Philips Respironics, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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