Sechrist Hyperbaric Chamber Software Bug Recall
Sechrist Industries is recalling 65 monoplace hyperbaric chambers to fix a software bug that could affect performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a software bug that could potentially affect performance, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Sechrist Industries Inc is recalling 65 units of the Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER. The recall covers 61 units in the United States and units distributed in Bulgaria and Canada. The affected serial numbers are 360001-360049, 360051-360064, and 360068.
The recall is being conducted to correct a software bug that could potentially affect the performance of the chamber. The device is intended to provide 100% oxygen to the patient at greater than ambient pressures.
Sechrist conducted a field upgrade on the affected chambers to address the issue. Users should contact Sechrist Industries Inc for information regarding the field upgrade.
The recalled product
- 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
- Manufacturer
- Sechrist Industries Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial Numbers: 360001-360049
- 360051-360064
- 360068.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Sechrist Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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