Recall Z-0209-2013 ยท CBF Chamber, Hyperbaric
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
| Date | Nov 6, 2012 (initiated Aug 28, 2008) |
| Status | Terminated |
| 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 |
| Quantity | 65 units total (61 units in the US) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER Sechrist Industries, Inc., Oct 28, 2005 |