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G5 NEOCUSSOR

GENERAL PHYSIOTHERAPY INC · Model NC90 · UDI-DI 00746980000004

BYI

510(k) clearances

282

Adverse events (6 deaths)

Recalls

Facilities

Description

The G5 Neocussor is a gentle, quiet, Directional-Stroking® model designed specifically for neonatal applications. The lungs of a neonate frequently cannot perform the cough mechanism due to their premature condition. The G5 Neocussor provides a soothing, precise treatment to help loosen, and help mobilize secretion build-up in neonates. It is small enough to fit inside infant environmental chambers; is powered by a single "C" cell replaceable battery, and weighs less than five ounces. Comes with two (2) Directional-Stroking disposable applicators and one vibration applicator. Unit Advantages: Soft rubber end cushions unit in the event of a fall. Red Arrow indicates the direction of fluid movement. Comes with three different applicators.

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.