Class 1 Device Recall Therapy Mask 3100

• Date Initiated by Firm: September 06, 2022
• Date Posted: September 30, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1784-2022
• Recall Event ID: 90705
• 510(K)Number: K210386
• Product Classification: Ventilator, non-continuous (respirator) - Product Code BZD
• Product: Therapy Mask 3100 NC/SP
• Code Information: All Units; Model No.: 1144608, 1144610, 1145038, 1145039, 1145040, 1145041, 1145044, 1145045, 1145046, 1145047, 1145048, 1145049, 1145050, 1145051, 1145052, 1145055, 1145056, 1145057, 1145058, 1145059, 1145060, 1145061, 1145062, 1145063, 1145064, 1145065, 1145066, 1145067, 1145068, 1145069, 1145070, 1145071, 1145072, 1145073, 1145074, 1145459, 1145460, 1145461, 1145462, 1145463, 1145464, 1145465, 1145466, 1145467, 1145478, 1145916, 1145917.
• Recalling Firm/ Manufacturer: Philips Respironics, Inc.; 1001 Murry Ridge Ln; Murrysville PA 15668-8517
• For Additional Information Contact: Philips Customer Service; 1-800-722-9377
• Manufacturer Reason for Recall: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.
• FDA Determined Cause: Error in labeling
• Action: The firm started notifying customers of this recall event via telephone on 9/6/2022. Additionally, customers were mailed an URGENT Medical Device Correction Letter dated 9/9/2022 that communicates that the firm is updating the Contraindications and Warning language for the Amara View Full Face Mask, DreamWisp Nasal Mask, DreamWear Full Face Mask, Wisp and Wisp Youth Nasal Mask, and Therapy Mask 3100 NC/SP due to the presence of magnets that may affect implanted medical devices and metallic splinters in the eye. All units of these masks are subject to this recall action. If a patient, a household member, caregiver, or bedpartner that is in close vicinity to patients using the mask is equipped with one of the medical devices or metallic splinters indicated in the updated Contraindications and Warning language, patients are to stop use of the affected mask and properly dispose of it once an alternative mask without magnets has been obtained after consultation with their healthcare provider. If the patient or others around them does not possess an implanted device or metal splinters included in the updated contraindications language, no action is needed. Users and those in the vicinity of the patient while using the mask must ensure the mask is kept at least six inches from medical implants and metallic splinters in the eye. Customers with any questions are to contact Philips Customer Care Solutions at 1-800-345-6443. The firm issued a press release on 9/6/22 and can be found at the following link: https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20220906-philips-respironics-alerts-customers-worldwide-of-updated-instructions-and-labeling-of-specific-sleep-therapy-masks-that-contain-magnetic-headgear-clips-due-to-potential-risk-of-serious-injury.html. A second Urgent Medical Device Correction Letter was sent to customers on 12/1/2022. Should DMEs, distributors, and prescribers decide to continue distributing masks and mask accessories with magnet
• Quantity in Commerce: 42,954 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BZD