Z-0209-2013Class II

Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is...

Name: Z-0209-2013 Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is...
Creator: Sechrist Industries Inc
Published: 2008-08-28
License: https://open.fda.gov/license/

Sechrist Industries Inc / initiated 2008-08-28 / Terminated / root cause: software

FDA source

Sechrist Industries Inc began a recall of Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at... on 2008-08-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0209-2013
Classification: Class II
Status: Terminated
Initiated: 2008-08-28
Posted: 2012-11-06
Terminated: 2012-11-06
Recalling firm: Sechrist Industries Inc
Product: 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
Product code: CBF Chamber, Hyperbaric
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 65 units total (61 units in the US)
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Product codes and lots: Serial Numbers: 360001-360049, 360051-360064, 360068.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0209-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0208-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06
Z-0209-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06

Product code CBF

K052713Class IIModel 3300E/er Monoplace Hyperbaric Oxygen ChamberSechrist Industries, Inc. / cleared 2005-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)