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.
- Hazard
- magnetic-interference
- implantable-device-risk
- missing-warning
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.
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