Percussionaire Impulsator and Phasitron 5 Recall for Anesthesia Warning Update
Percussionaire Corporation is recalling Impulsator and Phasitron 5 devices to update labeling warnings regarding the use of intrapulmonary percussive ventilation with volatile anesthetic delivery systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where specific physiological injuries (such as elevated intracranial pressure) are described as potential outcomes, but no reported illnesses or injuries are stated in the source text.
Plain-English summary
Percussionaire Corporation is recalling Impulsator (Product Number S00010) and Phasitron 5 (Product Number P5) devices used with Instruction Manual P20047 Rev E. The recall involves 228,277 units distributed worldwide, including across the United States and numerous international locations such as Canada, the United Kingdom, and Australia.
The recall is initiated to update labeling warnings against using intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems. The updated warning notes that IPV may alter the controlled delivery of volatile anesthetic agents, potentially resulting in deeper or lighter anesthetic effects. These effects may lead to hypertonia or hypotonia, tachycardia or bradycardia, elevated intracranial pressure, awareness during anesthesia, or oversedation.
Healthcare facilities and users of these devices should review the updated instruction manual and discontinue the use of IPV with volatile anesthetic delivery systems as directed by the new labeling. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
- Manufacturer
- Percussionaire Corporation
- Affected units
- 228,277
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 (3)
- Product Number/UDI-DI: S00010/00849436000389
- P5/00849436000501
- Instruction Manual: P20047 Rev E
Distribution
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