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Electro Flo® Percussor

MED SYSTEMS INC · Model 5000 · UDI-DI 00862528000302

BYI Prescription

510(k) clearances

289

Adverse events (6 deaths)

Recalls

Facilities

Description

The Electro Flo 5000 is an electrically powered percussor, intended to assist in airway clearance therapy when the physician’s choice of therapy is external manipulation of the thorax. Additionally, the Electro Flo 5000 is indicated for external manipulation of the thorax to promote airway clearance and improve bronchial drainage.

Recalls

Date	Firm	Reason
2021-03-31	Smiths Medical ASD Inc.	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.
2017-09-15	HILL-ROM MANUFACTURING, INC.	Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subje
2014-11-13	Aptalis Pharmatech Inc.	Customer notification that the device may be difficult to open or close.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.