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U.S. Department of Health and Human Services

Class 2 Device Recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module

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 Class 2 Device Recall Sechrist Monoplace Hyperbaric Chamber with Electronic Control Modulesee related information
Date Initiated by FirmAugust 28, 2008
Date PostedNovember 06, 2012
Recall Status1 Terminated 3 on November 06, 2012
Recall NumberZ-0208-2013
Recall Event ID 52796
510(K)NumberK052713 
Product Classification Chamber, hyperbaric - Product Code CBF
ProductSechrist 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.
Code Information Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075.
FEI Number 2020676
Recalling Firm/
Manufacturer		 Sechrist Industries Inc
4225 E La Palma Ave
Anaheim CA 92807
For Additional Information Contact
714-579-8400
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionSechrist 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.
Quantity in Commerce73 units
DistributionWorldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CBF
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