Philips Respironics Amara View Minimal Contact Full-Face Mask

FDA device recall Z-1780-2022 · posted 2022-09-30 · Open, Classified

Recall details

Recalling firm

Philips Respironics, Inc.

Reason for recall

No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes.

Action taken

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

Root cause

Error in labeling

Status

Open, Classified

Product code

BZD

Quantity affected

5,661,639 units

Distribution

Worldwide distribution - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinoi

Date initiated

2022-09-06

Date posted

2022-09-30

Location

Murrysville, PA

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