Device recall: Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended…
Class II FDA enforcement event 52796. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
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
Sechrist Industries Inc started this device recall on 28 Aug 2008. The firm address in the FDA record is in Anaheim, CA. FDA put the recall in Class II. FDA event 52796 has 2 product records. The first FDA enforcement report date is 14 Nov 2012. The record gives the status Terminated, with the termination date 6 Nov 2012.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
Recalling firm
Sechrist Industries Inc, Anaheim, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0208-2013 | 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. | 73 units | Class II | Terminated | 14 Nov 2012 |
| Z-0209-2013 | 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 | 65 units total (61 units in the US) | Class II | Terminated | 14 Nov 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2008
- 18
- Share of these events in Class II
- 89%
- Product records in this event
- 2Median of the firm: 2
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Jun 2015 | Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010 Event 71455 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0208-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 52796. https://recallregister.com/fda/ii/52796/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada
- What quantity of product is in FDA event 52796?
- The event has 2 product records. The first record gives this quantity:
73 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2008 have the same class?
- 89% of the 18 device events that started in 2008 are in Class II.