Device recall

Z-2230-2012: Serial interface module RS-232 Product Usage: The System 1 provides perfusion…

FDA device recall · Class II · Terumo Cardiovascular Systems Corporation

Key facts

Recall number (Z-number) Z-2230-2012
Recall event 62684
Product Serial interface module RS-232 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…
Product code DTQ
Recalling firm Terumo Cardiovascular Systems Corporation
Recall class Class II
Status Terminated
Termination date Jun 27, 2014
510(k) numbers K022947
FEI number 1828100

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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