Percussionaire Corporation recall (Class II): Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
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: Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
- Published by source
- 2026-10-07
- First seen by Reality Radar
- 2026-10-20
- Last verified
- 2026-10-20
Affected
- Manufacturer
- Percussionaire Corporation
- Products
- Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
Whether your exact unit is affected depends on the model, serial number and region in the official notice.
What the official notice says
Risk: Class II: 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
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Sources
- openFDA Recall Enforcement Reports Tier A · official published 2026-10-07
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