Central Control Module for System 1: System 1 Base — Class II medical device recall Z-1958-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-07-18, distributed nationwide. Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 lo
| Recall number | Z-1958-2012 |
|---|---|
| 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 | 2012-07-06 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-03-06 |
| 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, TH, TR, TW, VN, ZA |
| Quantity | 648 units |
| Reason classes | device malfunction |
| Serial numbers | 0006-0066, 0100-0311, 0313, 0322, 1001-1027, 1100-1434, 1436, 1440, 1441 |
| Model numbers | 801764 |
Product
Central Control Module for System 1: 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 CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM
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-1958-2012. 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.