The recall affects several models, including the Phasitron Kit VDR, Single-Patient and other related devices, according to an Feb. 10 news release from the FDA.
The issue was reported after a venturi component stopped oscillating during use, causing a patient’s oxygen levels to drop..
Healthcare providers are urged to immediately stop using the affected devices if a malfunction occurs and to closely monitor ventilated patients. Replacement products are also available through the devicemaker.
No injuries or deaths have been reported, according to the release.
