Serial interface module RS-485 Product Usage: The System 1 provides… — Class II medical device recall Z-2231-2012
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-2231-2012 |
|---|---|
| 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 | 34 units |
| Reason classes | device malfunction |
| Serial numbers | 00007-00038, 00041, 00043 |
| Model numbers | 803518 |
Product
Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data collected and exported by the data transfer module includes physiological data and device events to record the progress and events during a procedure.
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-2231-2012. 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.