Z-0208-2013 Class II Terminated
FDA device recall Z-0208-2013 was initiated by Sechrist Industries Inc on August 28, 2008 and is designated Class II. 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. The recall status is terminated (terminated November 6, 2012). Affected quantity: 73 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2012
- Initiation Date
- August 28, 2008
- Termination Date
- November 6, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 units
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Code Information
Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075.