Percussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
Percussionaire Corporation is recalling IPV-1C 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
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling update to prevent potential adverse health consequences from improper device use, fitting the criteria for moderate severity.
Plain-English summary
Percussionaire Corporation is recalling the Intrapulmonary Percussive Ventilation (IPV) IPV-1C (Product Number S00002-C) and Phasitron 5 (Product Number P5) devices, along with their associated Instruction Manual (P20045 Rev B). The recall involves 229,105 units distributed worldwide, including nationwide distribution across the United States and in numerous international countries.
The recall is initiated to update labeling to include a warning against using intrapulmonary percussive ventilation in conjunction with volatile anesthetic delivery systems. The updated warning notes that using IPV with these systems may alter the controlled delivery of volatile anesthetic agents. This alteration can result in deeper or lighter anesthetic effects, potentially leading to hypertonia or hypotonia, tachycardia or bradycardia, elevated intracranial pressure, awareness during anesthesia, or oversedation.
Healthcare facilities and users of the affected devices should review the updated labeling and discontinue the use of IPV in conjunction with volatile anesthetic delivery systems as directed by the new warnings. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
- Manufacturer
- Percussionaire Corporation
- Category
- Medical Device — Ventilation
- Affected units
- 229,105
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 (7)
- Product Number/UDI-DI: S00002-C/00849436000020
- 00849436000563
- 00849436000570
- 00849436000143
- 00849436000648
- P5/00849436000501
- Instruction Manual: P20045 Rev B
Distribution
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