Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator Sy...
FDA Device Recall #Z-0230-2016 — Class I — October 13, 2015
Recall Summary
| Recall Number | Z-0230-2016 |
| Classification | Class I — Serious risk |
| Date Initiated | October 13, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Event Medical LTD |
| Location | Lake Forest, CA |
| Product Type | Devices |
| Quantity | 6441 units total (251 units in US) |
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.
Distribution Pattern
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
Lot / Code Information
All models manufactured prior to 2015 are affected
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.