The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1780-2022·Announced 2022-10-12

CPAP Full-Face Mask Recalled for Missing Implantable Device Warnings

Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall, which carries a minimum severity of 4. While no deaths or injuries are reported in the source, the missing warnings about magnetic component interactions with implantable devices poses a significant risk to affected patient populations.

Plain-English summary

Philips Respironics is recalling all units of the Amara View Minimal Contact Full-Face Mask due to inadequate labeling and warnings. The Class I recall affects 5,661,639 units distributed worldwide.

The recalled masks lack necessary warnings and contraindications regarding magnetic components for patients with implantable medical devices (such as pacemakers, defibrillators, or cochlear implants) and those with metallic foreign bodies, including splinters, in their eyes. Magnetic fields from the mask's components could potentially interfere with electronic implants or attract metallic objects.

Patients using this mask who have implantable medical devices or metallic objects in their eyes should contact their healthcare provider immediately. Healthcare providers should evaluate patient risk and determine whether alternative CPAP mask options are appropriate.

The recalled product

Product
Philips Respironics Amara View Minimal Contact Full-Face Mask
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory / CPAP Equipment
Hazard
Affected units
5,661,639

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • All Units
  • Model No: 1090602
  • 1090603
  • 1090604
  • 1090622
  • 1090623
  • 1090624
  • 1090641
  • 1090642
  • 1090643
  • 1090644
  • 1090651
  • 1090652
  • 1090653
  • 1090654
  • 1090662
  • 1090663
  • 1090664
  • 1090670
  • 1090696

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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