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PCCI Hyperbaric Systems

PCCI HYPERBARIC SYSTEMS · Model Althea 4200 · UDI-DI 00850011262016

CBF

510(k) clearances

153

Adverse events (12 deaths)

Recalls

Facilities

Description

The Althea 4200 chamber system is a monoplace hyperbaric chamber outfitted with a large round door. The chamber is pressurized with air, and oxygen is delivered via hood or mask. Pressure and depressurization controls can either be operated manually or automatically. The chamber includes an intercom system that allows two-way communication between the operator and the patient. The chamber is designed to fit through a commonly available 48” doorway.

Recalls

Date	Firm	Reason
2014-08-08	Baro-Therapies, Inc	The firm is distributing the Rejuvenator device without an approved 510(k).
2008-08-28	Sechrist Industries Inc	Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform
2008-08-28	Sechrist Industries Inc	Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the perform

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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.