System 1 Base — Class II medical device recall Z-1965-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-07-18, distributed in AL, AZ, CA, CO, CT, DE, FL, GA…. Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during periods of sys
| Recall number | Z-1965-2012 |
|---|---|
| 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 | 2012-07-09 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-11-08 |
| Distributed | AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AE, DE, EG, HK, HN, ID, IN, JO, JP, KR, KW, MX, MY, PH, PK, RU, SA, SG, TH, TR, TW, VN, ZA |
| Quantity | 993 units |
| 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 in 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 battery charge is being depleted faster than expected during periods of system shutdown. The System 1 may falsely indicate a longer battery life than actual battery time remaining if not subjected to regular use, such as would occur with a backup system. This may result in unexpected system shutdown. Prolonged battery depletion may cause permanent battery damage.
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-1965-2012. 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.