Summary
The FDA issued a Class I for DreamWisp Nasal Mask with Over the Nose Cushion by Philips Respironics, Inc.. Reason: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes..
Details
Source
Device Recall
External ID
Z-1782-2022
Action Date
2022-10-12
Status
Ongoing
Category
device
Product Description
DreamWisp Nasal Mask with Over the Nose Cushion
Lot/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.
Quantity Affected: 930,813 units
Reason for Recall
No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-06
Company
Murrysville, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 165 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Respironics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips Respironics, Inc. have FDA actions?
Philips Respironics, Inc. has 74 FDA actions in our database, including 74 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1782-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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