Key takeaways:
- The US Food and Drug Administration (FDA) has issued a Class I recall for certain Philips Respironics DreamStation1 CPAP machines due to a potential risk of serious injury or death.
- The recall is due to some devices being assigned incorrect or duplicate serial numbers during initial programming.
- Philips is offering a free replacement device to customers affected by the recall.
The US Food and Drug Administration (FDA) has issued a Class I recall for certain Philips Respironics DreamStation1 CPAP machines due to a potential risk of serious injury or death. The recall comes after Philips recalled more than 5 million continuous positive airway pressure (CPAP) machines in June 2021 due to foam inside the units breaking off and blowing into users’ mouths.
The FDA’s Class I recall is the most serious type of recall and indicates that there is a reasonable probability that the product could cause serious adverse health consequences or death. The recall is due to some devices being assigned incorrect or duplicate serial numbers during initial programming.
Inhaling the foam from the recalled CPAP machines can cause serious injury which can be life-threatening, according to Philips. The company has urged customers to stop using the machines immediately and contact their healthcare provider if they have any questions or concerns.
The FDA is urging healthcare providers and patients to be aware of the recall and to report any adverse events or side effects related to the use of the recalled devices. Patients should contact their healthcare provider if they have any questions or concerns.
Philips is offering a free replacement device to customers affected by the recall. Customers can contact Philips directly for more information or to arrange for a replacement device.
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