Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperb...

FDA Recall #Z-0208-2013 — Class II — August 28, 2008

Recall #Z-0208-2013 Date: August 28, 2008 Classification: Class II Status: Terminated

Product Description

Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.

Reason for Recall

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 performance of the chamber.

Recalling Firm

Sechrist Industries Inc — Anaheim, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

73 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada

Code Information

Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated