Percussor, Powered-electric
Anesthesiology · 21 CFR 868.5665
Recent MDR events
282 adverse event reports on file
- SMARTVEST CLEARWAYJul 10, 2026InjuryElectromed, Inc.3003007907-2026-00003
- THE VEST SYSTEMJul 10, 2026MalfunctionBaxter Healthcare Corporation3008145987-2026-00056
- THE VEST APX SYSTEMJul 2, 2026InjuryBaxter Healthcare Corporation3008145987-2026-00052
- INCOURAGE DEVICEJun 30, 2026InjuryRespiratory Technologies, Inc3004961434-2026-00006
- THE VEST APX SYSTEMJun 29, 2026InjuryBaxter Healthcare Corporation3008145987-2026-00051
- THE VEST APX SYSTEMJun 24, 2026InjuryBaxter Healthcare Corporation3008145987-2026-00050
- THE VEST SYSTEMJun 19, 2026MalfunctionBaxter Healthcare Corporation3008145987-2026-00047
- INCOURAGE DEVICEJun 17, 2026InjuryRespiratory Technologies, Inc3004961434-2026-00005
- THE VEST SYSTEMJun 8, 2026MalfunctionBaxter Healthcare Corporation3008145987-2026-00041
- INCOURAGE DEVICEJun 5, 2026InjuryRespiratory Technologies, Inc3004961434-2026-00004
Event type breakdown
Recalls
3 recall events for this product code
- Aptalis Pharmatech Inc.TerminatedJan 22, 2015
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package.
Customer notification that the device may be difficult to open or close.
Z-1006-2015 · View FDA record ↗ - HILL-ROM MANUFACTURING, INC.TerminatedUnknown
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on th
Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device.
Z-0192-2018 · View FDA record ↗ - Smiths Medical ASD Inc.TerminatedUnknown
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
Z-1515-2021 · View FDA record ↗
Registered firms
47 firms currently registered for this product code
Hill-rom Services Private Limited
Singapore North East, SG
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Hill-rom Manufacturing, Inc.
SAINT PAUL, MN, US
Isomedix Operations, Inc
ONTARIO, CA, US
Sterigenics Us Llc
Fort Worth, TX, US
Electromed, Inc.
NEW PRAGUE, MN, US
Clement Clarke Intl., Ltd.
Mountain Ash Rhondda Cynon Taff, GB
Multisource Manufacturing Llc
Longmont, CO, US
Pulmodyne Inc.
Indianapolis, IN, US
Core Products International Inc
Chetek, WI, US
Icu Medical, Inc.
SAN CLEMENTE, CA, US
Tactile Systems Technology Inc
New Brighton, MN, US
Philips Electronics Ltd
Mississauga Ontario, CA
Flextronics Manufacturing (singapore) Pte Ltd
SINGAPORE South East, SG
Avanos Medical, Inc.
Alpharetta, GA, US
Med Systems
SAN DIEGO, CA, US
Nextern Costa Rica Ltd.
Cartago, CR
Better Breathing Devices Pty Ltd
Tweed Heads South New South Wales, AU
Welch Allyn De Mexico, S. De R.l. De C.v.
TIJUANA Baja California, MX
Icu Medical, Inc.
DUBLIN, OH, US
510(k) clearances
58 clearances for this product code
- Tactile MedicalApr 30, 2026
K252849 · AffloVest® Mobile Airway Clearance Therapy
- Exemplar Medical, LLCOct 2, 2025
K250860 · BreatheBand® (Model 1000)
- Synchrony Medical , Ltd.Dec 19, 2024
K242063 · LibAirty Airway Clearance System
- Chongqing Moffy Innovation Technology Co., Ltd.Dec 18, 2024
K240959 · Respiratory Muscle Trainer
- Baxter Healthcare CorportationMar 22, 2024
K233441 · The Vest APX System (PVAPX1)
- Electromed, Inc.Nov 18, 2022
K222496 · Electromed SmartVest Airway Clearance System
- Med Systems, Inc.Feb 12, 2021
K201490 · Electro Flo 6 Airway Clearance System
- Airphysio Pty, Ltd.Jan 15, 2021
K203209 · AirPhysio Positive Expiratory Pressure (PEP) Device