Percussionaire F00001-C-FR (REF S00002-C-FR1)Recalls & reported problems
Percussionaire Corporation · F00001-C, IPV1-C, French, Dual Gas, DISS-OXY, NIST-AIR, Europe · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 2 still open.
1 other recall cover devices cleared under the same FDA submission (K905236); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Aug 18, 2026Open, Classified
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
Z-3321-2026 · Root cause: Device Design · FDA record ↗
- Aug 18, 2026Open, Classified
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
Z-3322-2026 · Root cause: Device Design · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K905236. One submission often covers many models, so check the product and lot details in each record.
- Z-0208-2025 · Sep 16, 2024 · Open, ClassifiedPhasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Other Device, Positive Pressure Breathing, Intermittent devices
- Percussionaire P5Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent4 recalls2 reports
- Volara System M08473Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT3 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls3 reports
- Volara System M08085Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT2 recalls0 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Volara System M07937Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.