Device 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
Z-0209-2013
Product summary
- Event
- Event 52796
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 units total (61 units in the US)
- Official record key
device-enforcement:Z-0209-2013
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: 360001-360049, 360051-360064, 360068.
Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Derived failure modes
-
Device software or design
software bug