Recall Z-0031-2026 ยท BZO Set, Tubing And Support, Ventilator (W Harness)
Percussionaire Corporation
Phasitron 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
| Date | Oct 14, 2025 (initiated Sep 17, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | On 9/17/2025, correction notices were emailed to customers who were informed of future design update and current instructions for use update, and advised: If adequate exhaled tidal volumes cannot be achieved with the In-Line Valve in place, consider removing the IN-Line Valve from the circuit when IPV therapy is not being delivered or choose a different treatment configuration (e.g., direct to artificial airway). Insufficient exhaled tidal volumes may lead to hypoventilation. At initial placement of the In-Line Valve in the inspiratory limb: (either at the patient wye or on the dry side of |
| Quantity | 59160 |
| Distribution | Worldwide distribution. US nationwide, Russia, Japan, Switzerland, Canada, Qatar, Chile, South Africa, United Kingdom, Israel, Turkey, and UAE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.