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Recall Observatory FDA recall evidence

Device product

Sechrist 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.

Z-0208-2013

August 28, 2008

Class II

Product summary

Firm
Sechrist Industries Inc
Event
Event 52796
Status
Terminated
Classification
Class II
Quantity
73 units
Official record key
device-enforcement:Z-0208-2013

Official wording

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.

Code information: Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075.

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software bug