System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is… — Class II medical device recall Z-2056-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-08-01, distributed nationwide. Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failu
| Recall number | Z-2056-2012 |
|---|---|
| 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 | 2012-06-22 |
| Classified | 2012-07-20 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2013-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BE, CA, CL, CO, CR, DE, DO, EG, HK, HN, ID, IL, IN, JO, JP, KR, KW, MX, MY, PH, PK, RU, SA, SG, TR, TW, VN, ZA |
| Quantity | 640 devices |
| Serial numbers | 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1429 |
| Model numbers | 801764 |
Product
System 1 Base 220/240V 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 Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of drive motor failure of the Sarns Centrifugal System of the Terumo Advanced Perfusion System 1. A failure of the drive motor for the Terumo System 1 centrifugal system triggers error messages and alarms; therefore it is easily recognizable by the user. The potential hazards are dependent on the application
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-2056-2012. 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.