Interface module for CDl System 500 Product Usage: The Interface… — Class II medical device recall Z-2233-2012
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-08-29, distributed nationwide. Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabil
| Recall number | Z-2233-2012 |
|---|---|
| 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 | 2012-07-26 |
| Classified | 2012-08-20 |
| Reported by FDA | 2012-08-29 |
| Terminated | 2014-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CL, CO, CR, DE, DO, HK, ID, JO, JP, KR, MY, SG, TH, TW, VN, ZA |
| Quantity | 582 units |
| Reason classes | device malfunction |
| Serial numbers | 00009-00122, 00124-00210, 00213-00365, 00367-00458, 00461-00596 |
| Model numbers | 803479 |
Product
Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data from the CDl 500
Reason for recall
Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data transfer capabilities using the data transfer capabilities using modules on the Terumo Advanced Perfusion System 1. Some reports stated that the odor of smoke was as associated with the failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modu
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-2233-2012. 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.