Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported November 25, 2015
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Event Medical LTD recalled Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Venti… - a critical-severity action.
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Venti… was recalled by Event Medical LTD in November 25, 2015. Reason: A component on the systems power board can fail in a manner which can cause the ventilator to shut down witho…. Check the official notice for the remedy. Verify recall #Z-0230-2016 with the FDA Devices before acting.
The recall
Event Medical LTD issued this critical-severity FDA Devices recall-A component on the systems power board can fail in a manner which can cause the ventilator to shut down witho….
- Critical
- severity level
- 6K units
- affected scope
- Class I
- classification
- November 25, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0230-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0230-2016) was formally reported on November 25, 2015, with the manufacturer initiating the action on October 13, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Event Medical LTD is listed as the recalling firm, operating out of Lake Forest, CA. Federal records list the affected scope as 6441 units total (251 units in US).
The documented reason for this recall is: A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) and Internationally to: Algeria Argentina Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bolivia Canada Chile China Colombia Czech Rep Ecuador Egy…. 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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
6441 units total (251 units in US)
Related Recalls
6
3 from same agency
Product description
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
Reason for recall
A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0230-2016 |
| Date reported | November 25, 2015 |
| Date initiated | October 13, 2015 |
| Recalling firm | Event Medical LTD |
| Firm location | Lake Forest, CA |
| Affected scope | 6441 units total (251 units in US) |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to: Algeria Argentina Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bolivia Canada Chile China Colombia Czech Rep Ecuador Egypt England Estonia… |
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-0230-2016) 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? ▼
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.. Recalled by Event Medical LTD. Units affected: 6441 units total (251 units in US).
Why was this product recalled? ▼
A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2015. Severity: Critical. Recall number: Z-0230-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to: Algeria Argentina Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bolivia Canada Chile China Colombia Czech Rep Ecuador Egypt England Estonia Finland Germany Ghana Gibraltar Greece Guatemala Holland Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kenya Korea Kuwait Laos Latin America Lebanon Libya Lithuania Malaysia Mexico Morocco Nepal Netherlands New Zealand Norway Pakistan Palestine Panama Peru Philippines Poland Portugal Russia Saudi Arabia Serbia Singapore South Africa Spain Sri Lanka Sudan Switzerland Syria Taiwan Thailand Turkey UAE Ukraine USA Venezuela Vietnam Yemen Zimbabwe.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0230-2016) 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 November 25, 2015. 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 July 2026.