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.
FDA Recall Z-0208-2013 · Posted 2012-11-06
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Recalling FirmSechrist Industries Inc
Recall StatusTerminated
Product CodeCBF
Date Initiated2008-08-28
Date Terminated2012-11-06
Product Quantity73 units
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.
Firm Action
Sechrist Industries contacted consignees by phone to notify them of a software upgarde and to schedule appointments to perform the required field upgrades. An approximate summary of the phone notification is provided below.
"I am contacting you to notify you of a field upgrade we are performing on our
hyperbaric chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of your chamber. The upgrade includes the installation of a new motherboard with revised software, a reset switch, and the exchange of other control panel components. The process will take approximately 2.5 hours and will be performed at no charge to you."
For questions regarding this recall call 714-579-8400.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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