Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System — Class II medical device recall Z-0176-2019
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2018-10-24, distributed nationwide. The service manual was not updated at the time of the release of software version 1.30.
| Recall number | Z-0176-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2018-09-13 |
| Classified | 2018-10-18 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2019-11-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BD, BE, CA, CL, CN, DE, DO, EC, FR, GT, ID, IN, JP, KR, KW, LK, MX, MY, NZ, PA, PH, SG, SV, TH, TW, VN, ZA |
| Quantity | 152 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00886799000588 |
| Model numbers | 801188 |
Product
Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188
Reason for recall
The service manual was not updated at the time of the release of software version 1.30.
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-0176-2019. 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.