Percussionaire Corporation
8 federal recalls on file, showing the 1 from the last 12 months. 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.
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