The Recall Desk
SevereFDA (Devices)·Z-1784-2022·Announced 2022-10-12

Therapy Mask 3100 NC/SP lacks warnings for implantable medical devices

Philips Respironics is recalling the Therapy Mask 3100 NC/SP because the product lacks warnings about magnetic components that may affect patients with implantable devices or metallic splinters in the eyes.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall. The hazard involves potential interference with implantable medical devices, which presents a risk of serious injury or harm to affected patients, meeting the Severe classification criterion.

Plain-English summary

Philips Respironics, Inc. is recalling the Therapy Mask 3100 NC/SP due to missing contraindications and warnings regarding magnetic components in the mask. The mask contains magnetic elements that could pose a hazard to patients with implantable medical devices or those with metallic splinters in their eyes, but the product labeling does not include appropriate warnings about these risks.

Approximately 42,954 units have been distributed worldwide, including throughout all 50 U.S. states and numerous countries. The recall affects all model numbers associated with this product.

Patients who use this mask and have implantable devices (such as pacemakers or defibrillators) or metallic splinters in their eyes should contact their healthcare provider immediately to discuss the risks. Consumers should stop using the mask if they have either of these conditions and consult with their physician about alternative options.

The recalled product

Product
Therapy Mask 3100 NC/SP
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — CPAP / Respiratory mask
Hazard
Affected units
42,954

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.: 1144608
  • 1144610
  • 1145038
  • 1145039
  • 1145040
  • 1145041
  • 1145044
  • 1145045
  • 1145046
  • 1145047
  • 1145048
  • 1145049
  • 1145050
  • 1145051
  • 1145052
  • 1145055
  • 1145056
  • 1145057
  • 1145058

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 →

Related recalls

Same manufacturer · Philips Respironics, Inc.

See all →

Same hazard · magnetic interference

See all →