Recall Z-1784-2022— Philips Respironics, Inc.

Name: FDA recall Z-1784-2022
Creator: U.S. Food and Drug Administration
Published: 2022-09-06

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2022-09-06. It names one FDA 510(k) clearance: K210386. Product: Therapy Mask 3100 NC/SP. Reason: No contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2022-09-06
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K210386 — Magneto Nasal MaskRespironics, Inc.·cleared 2021-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Therapy Mask 3100 NC/SP

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.