Reported Aug 29, 2012 · Terminated
Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the…
Terumo Cardiovascular Systems Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Cardiovascular Systems Corporation · 6200 Jackson Road · Ann Arbor, MI · 48103-9586
Is this the product you have?
- Serial
- interface module RS-485 Product UsageThe 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
- Lot codes and dates
- catalog number803518
- and serial numbers
00007-0003800041and 00043
- Amount recalled
- 34 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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