System 1 Base — Class II medical device recall Z-2020-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-07-25, distributed nationwide. Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a
| Recall number | Z-2020-2012 |
|---|---|
| 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 | 2012-06-21 |
| Classified | 2012-07-16 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-03-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BE, CA, CL, CO, CR, DE, DO, EG, GT, HK, HN, ID, IL, IN, JO, JP, KR, KW, MX, MY, PH, PK, RU, SA, SG, TR, TW, VN, ZA |
| Quantity | 992 |
| Reason classes | device malfunction |
| Serial numbers | 0011-0335, 0337-0610, 1001, 1034, 1037-1049, 1100, 1103-1106, 1109-1445, 1447-1450 |
| Model numbers | 801763 |
Product
System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Reason for recall
Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or
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-2020-2012. 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.