Inspiration Ventilator System — Class I medical device recall Z-0230-2016
Terminated recall by Event Medical LTD, reported 2015-11-25, distributed nationwide. A component on the systems power board can fail in a manner which can cause the ventilator to shut down withou
| Recall number | Z-0230-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Event Medical LTD, Lake Forest, CA, United States |
| Recall initiated | 2015-10-13 |
| Classified | 2015-11-19 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-06-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BH, BO, CA, CH, CL, CN, CO, CZ, DE, DZ, EC, EE, EG, ES, FI, GB, GH, GR, GT, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, MA, MX, MY, NL, NO, NP, NZ, PA, PE, PH, PK, PL, PT, RS, RU, SA, SG, TH, TR, TW, UA, VE, VN, ZA |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0230-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.