Phantom 2 Nasal Vented Mask recalled due to magnetic device interference risk
SleepNet is recalling the Phantom 2 Nasal Vented Mask to update contraindications and warning information related to magnets in the device. The recall affects 2,417 units distributed worldwide.
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: FDA Class I medical device recalls require a minimum score of 4 per recall classification rules. Although no illnesses or injuries have been reported, the recall addresses magnets in the device that require updated contraindications and warning language, indicating a serious potential hazard.
Plain-English summary
SleepNet Corporation is recalling the Phantom 2 Nasal Vented Mask, a CPAP sleep apnea treatment device. The recall is due to magnets contained in the mask that require updates to contraindications and warning language.
The recall affects 2,417 units bearing all UDI-DI codes and lot numbers. The product has been distributed worldwide, including throughout the United States and more than 40 countries.
Patients using the Phantom 2 Nasal Vented Mask should contact SleepNet Corporation or consult their healthcare provider for updated contraindications and safety information specific to the magnets in this device.
The recalled product
- Product
- Phantom 2 Nasal Vented Mask
- Manufacturer
- SleepNet Corporation
- Hazard
- magnetic-interference
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 (2)
- All UDI-DI
- All Lot Numbers.
Distribution
Distributed nationwide across the United States.
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