Device recall: e500 Automatic Transport Ventilator, Model Number 01EVE500
Class I FDA enforcement event 82178. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
O-Two Medical Technologies, Inc. started this device recall on 12 Feb 2019. The firm address in the FDA record is in Brampton, Ontario. FDA put the recall in Class I. FDA event 82178 has 3 product records. The first FDA enforcement report date is 10 Apr 2019. The record gives the status Terminated, with the termination date 29 Jun 2023.
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.
The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
Recalling firm
O-Two Medical Technologies, Inc., Brampton, Ontario, Canada.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0976-2019 | e500 Automatic Transport Ventilator, Model Number 01EVE500 | 136 | Class I | Terminated | 10 Apr 2019 |
| Z-0977-2019 | e600 Automatic Transport Ventilator, Model Number 01EVE600 | 119 | Class I | Terminated | 10 Apr 2019 |
| Z-0978-2019 | e700 Automatic Transport Ventilator, Model Number 01EVE700 | 632 | Class I | Terminated | 10 Apr 2019 |
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 I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class I
- 6%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 May 2018 | O-Two Equinox Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000 | Device | Class II | 1 |
| 30 Sep 2015 | Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 -- | Device | Class II | 1 |
| 23 Jun 2015 | O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- I | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0976-2019The 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.
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Cite this page
Recall Register. FDA enforcement event 82178. https://recallregister.com/fda/i/82178/. 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:
The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.
- What quantity of product is in FDA event 82178?
- The event has 3 product records. The first record gives this quantity:
136
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 6% of the 968 device events that started in 2019 are in Class I.