Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported April 10, 2019
e600 Automatic Transport Ventilator, Model Number 01EVE600
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 tha…
O-Two Medical Technologies, Inc. recalled e600 Automatic Transport Ventilator, Model Number 01EVE600 - a critical-severity action.
e600 Automatic Transport Ventilator, Model Number 01EVE600 was recalled by O-Two Medical Technologies, Inc. in April 10, 2019. Reason: There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly i…. Check the official notice for the remedy. Verify recall #Z-0977-2019 with the FDA Devices before acting.
The recall
O-Two Medical Technologies, Inc. issued this critical-severity FDA Devices recall-There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly i….
- Critical
- severity level
- 119 units
- affected scope
- Class I
- classification
- April 10, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0977-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0977-2019) was formally reported on April 10, 2019, with the manufacturer initiating the action on February 12, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. O-Two Medical Technologies, Inc. is listed as the recalling firm, operating out of Brampton, Ontario. Federal records list the affected scope as 119.
The documented reason for this recall is: 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 unde… Distribution data in the federal record shows the product reached: The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
119
Related Recalls
6
6 from same agency
Product description
e600 Automatic Transport Ventilator, Model Number 01EVE600
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0977-2019 |
| Date reported | April 10, 2019 |
| Date initiated | February 12, 2019 |
| Recalling firm | O-Two Medical Technologies, Inc. |
| Firm location | Brampton, Ontario |
| Affected scope | 119 |
| Distribution | The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0977-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
e600 Automatic Transport Ventilator, Model Number 01EVE600. Recalled by O-Two Medical Technologies, Inc.. Units affected: 119.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 10, 2019. Severity: Critical. Recall number: Z-0977-2019.
Where was the recalled product distributed? ▼
Distribution: The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0977-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 10, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.