14
Nov
2012

Cl ll Sechrist Monoplace Hyperbaric Chamber

0

Company:Sechrist Industries Inc
Date of Enforcement Report 11/14/12
Class ll:

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. Recall Number Z-0208-2013 and Z-0209-2013

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.

RECALLING FIRM/MANUFACTURER
Sechrist Industries Inc. Anaheim, CA on 8/28/2008. Voluntary: Firm Initiated recall has been terminated

VOLUME OF PRODUCT IN COMMERCE
73 units recall Z-0208-2013
65 units recall Z-0209-2013

DISTRIBUTION
Nationwide, Canada and Bulgaria

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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