CLASS II Device recall · Reported 14 Nov 2012 · FDA Enforcement Report
Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module recalled
Sechrist Industries is recalling Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module, distributed nationwide in the US. The recall was initiated on 28 Aug 2008 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0209-2013
- FDA event ID
- 52796
- Recalling firm
- Sechrist Industries, Anaheim, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2008
- FDA classified
- 6 Nov 2012
- Reported
- 14 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 28 Aug 2008 | Recall initiated by company | |
| 6 Nov 2012 | Classified by FDA | +1531 days |
| 14 Nov 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Questions about this recall
Is Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module recalled?
Yes. Sechrist Industries recalled Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module on 28 Aug 2008. The recall is Class II and its status is Terminated. Recall number Z-0209-2013.
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 360001-360049, 360051-360064, 360068.
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sechrist Industries
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|---|---|---|---|---|---|
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| Device | CLASS II | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module recalled | Sechrist Industries | Device Malfunction | Nationwide |
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