Recall Z-1784-2022 ยท BZD Ventilator, Non-Continuous (Respirator)
Philips Respironics, Inc.
Therapy Mask 3100 NC/SP
| Date | Sep 30, 2022 (initiated Sep 6, 2022) |
| Status | Open, Classified |
| Reason | No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. |
| Root 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 househo |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210386 | Magneto Nasal Mask Respironics, Inc., Jul 12, 2021 |