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U.S. Department of Health and Human Services

Enforcement Report - Week of November 14, 2012

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Event Detail

Event ID 52796
Product Type Devices
Status Terminated
Recalling Firm Sechrist Industries Inc
City Anaheim
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2008-08-28
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075. Class II 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. 73 units Z-0208-2013
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures Serial Numbers: 360001-360049, 360051-360064, 360068. Class II 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. 65 units total (61 units in the US) Z-0209-2013
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