Philips Respironics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1783-2022)
See the recall detail below. You can also see other recalls from the same firm in 2022.
Wisp and Wisp Youth Nasal Mask
Class I
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
All Units; Model No.: 1094050, 1094051, 1094053, 1094060, 1094061, 1094062, 1094070, 1094071, 1094072, 1094073, 1109298, 1113954, 1117119, 1118060, 1118061, 1118062, 1118063, 1118064, 1118065, 1118066, 1118067, 1120434, 1137360, 1137361, 1137366, 1137367, 1137368, 1137369, 1137370, 1138989, 1138991, 1138992, 1138993, 1138994, 1138995, 1138996, 1139009, 1148366, 1094051RTL.
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.
Voluntary: Firm initiated