Recall Z-0208-2013— Sechrist Industries Inc

Name: FDA recall Z-0208-2013
Creator: U.S. Food and Drug Administration
Published: 2008-08-28

Class II · Terminated

Class II FDA medical device recall by Sechrist Industries Inc, initiated 2008-08-28, terminated 2012-11-06. It names one FDA 510(k) clearance: K052713. Product: 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: 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
Classification: Class II
Status: Terminated
Initiated: 2008-08-28
Terminated: 2012-11-06
Firm location: Anaheim, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K052713 — MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBERSechrist Industries, Inc.·cleared 2005-10-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.