FDA Device recall Z-3323-2026
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual by Percussionaire, citing labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3323-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-18 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Percussionaire |
| Distribution | US |
Product
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
Reason
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Identifiers
| code_info | Product Number/UDI-DI: S00010/00849436000389, P5/00849436000501, Instruction Manual: P20047 Rev E |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Percussionaire
- Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C
FDA Device · Class II · 2026-10-07 · Percussionaire - In-Line Valve, Product Number: P5-TEE
FDA Device · Class II · 2026-10-07 · Percussionaire - Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065
FDA Device · Class II · 2026-10-07 · Percussionaire - Travel Air, Product Number: S00055
FDA Device · Class II · 2026-10-07 · Percussionaire - Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009
FDA Device · Class II · 2026-10-07 · Percussionaire
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3323-2026%22
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