Sechrist Hyperbaric Chamber Software Bug Recall
Sechrist Industries is recalling 73 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software bug could affect performance, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Sechrist Industries Inc is recalling 73 units of the Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER. The recall is due to a software bug that could potentially affect the performance of the chamber.
The affected units were distributed worldwide, including the United States, Bulgaria, and Canada. The specific serial numbers involved are 330001-330069, 330071, 330072, 330074, and 330075.
Sechrist conducted a field upgrade on the affected chambers to correct the software bug. Users should check their serial numbers against the list provided by the manufacturer.
The recalled product
- 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.
- Manufacturer
- Sechrist Industries Inc
- Affected units
- 73
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 (5)
- Serial Numbers: 330001-330069
- 330071
- 330072
- 330074
- 330075.
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.
See all 2 products in this recall →Related recalls
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