Official recall notice
Intrapulmonary Percussive Ventilation IPV-2C Recall (Oct 2026)
Product: Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
- Recall date
- 2026-10-07
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Product description
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Affected products
Product Number/UDI-DI: S00002-C/00849436000020, 00849436000563, 00849436000570, 00849436000143, 00849436000648; P5/00849436000501; Instruction Manual: P20046 Rev A