Sechrist Monoplace Hyperbaric Chamber with Electronic… recallZ-0209-2013 · Sechrist Industries Inc · initiated Aug 28, 2008
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sechrist Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0209-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 28, 2008
- Posted by the FDA
- Nov 6, 2012
- Recalling firm
- Sechrist Industries Inc
- Quantity
- 65 units total (61 units in the US)
- Product code
- CBF
- FDA submissions
- K052713
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Product description
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
Code information (models, lots, serial numbers)
Serial Numbers: 360001-360049, 360051-360064, 360068.
Other devices under the same FDA submission
2 devices cleared under K052713 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sechrist Industries, Inc. 3600ER-00Sechrist Industries, Inc. · Chamber, Hyperbaric2 reports
- Sechrist Industries, Inc. 3600E-00Sechrist Industries, Inc. · Chamber, Hyperbaric1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 52796).
- Z-0208-2013 · TerminatedSechrist 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 ambien…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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