Terumo Advanced Perfusion System 1 Serial Interface Module Recall
Terumo is recalling 34 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions and smoke odor.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with reported malfunctions and smoke odor, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 34 units of the Serial Interface Module RS-485 used with the Terumo Advanced Perfusion System 1. The module is a general-purpose serial interface that transfers perfusion case data, including physiological data and device events, between the system and data management software.
The recall was initiated after the company received reports of malfunctions involving the loss of data transfer capabilities. Some reports indicated that the odor of smoke was associated with these failures. The malfunctions occurred during set-up, during cardiopulmonary bypass, and during routine testing of the modules.
The affected units are identified by catalog number 803518 and serial numbers 00007-00038, 00041, and 00043. These modules were distributed worldwide, including nationwide in the United States and in various international markets. Users should contact Terumo Cardiovascular Systems Corporation for further instructions regarding the recall.
The recalled product
- 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
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Hazard
- Affected units
- 34
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- catalog number: 803518 and serial numbers:00007-00038
- 00041
- and 00043.
Distribution
Part of a larger recall action
This product is one of 4 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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