Percussionaire Corporation
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Percussionaire Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-22FDA-DeviceClass IPhasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
- 2025-01-29FDA-DeviceClass IVDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
- 2024-11-06FDA-DeviceClass IPhasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
As a result of product complaints, breathing circuits are experiencing discolored fluid which are formed when therapy was being given with specific medication through the nebulizer cup. Discoloration is caused by a reaction between medicated mist and an inadvertent/unapproved addition of a nickel coating on the spring component.
- 2024-10-09FDA-DeviceClass IPercussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
- 2024-10-09FDA-DeviceClass IPercussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.
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