Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended t
FDA device recall Z-0208-2013 · posted 2012-11-06 · Terminated
Recall details
- Recalling firm
- Sechrist Industries Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- CBF
- Quantity affected
- 73 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
- Date initiated
- 2008-08-28
- Date posted
- 2012-11-06
- Date terminated
- 2012-11-06
- Location
- Anaheim, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER (K052713) | Sechrist Industries, Inc. | 2005-10-28 |