FDA Medical Device Recalls (openFDA)
Sechrist Industries Inc: 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
- Recall number
- Z-0209-2013
- 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
- Status
- Terminated
- Initiated
- 2008-08-28
- Posted
- 2012-11-06
- Terminated
- 2012-11-06
- Reason
- 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
- 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
- 65 units total (61 units in the US)
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
- Lot, serial or model codes
- Serial Numbers: 360001-360049, 360051-360064, 360068.
- 510(k) numbers
- ["K052713"]
- PMA numbers
- not on file
- Product code
- CBF
- Firm FEI
- 2020676
- Firm city
- Anaheim
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28