Z-2231-2012Class II

Serial interface module RS-485

Name: Z-2231-2012 Serial interface module RS-485
Creator: Terumo Cardiovascular Systems Corporation
Published: 2012-07-26
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2012-07-26 / Terminated / root cause: design

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 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... on 2012-07-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2231-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-26
Posted: 2012-08-21
Terminated: 2014-06-27
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
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
Root cause tag: design
FDA root cause: Device Design
Action: Terumo sent an URGENT MEDICAL DEVICE Recall letter dated July 24, 2012 to all affected customers. The letter identified the affected product, reason for correction, potential hazard and actions to be taken. The letter stated that Terumo CVS will replace all affected modules. Customers were informed that a Terumo VS Representative will contact the user to schedule a service call for the replacement upon receipt of the Response Form attached. For questions contact Terumo CVS Customer Service at 800-521-2818.
Quantity in commerce: 34 units
Distribution: Worldwide Distribution - US Nationwide including the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV and the countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Germany, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Singapore, South Africa, South Korea, Taiwan, Thailand, UNITED ARAB EMIRATES (UAE), and Vietnam
Product codes and lots: catalog number: 803518 and serial numbers:00007-00038, 00041, and 00043.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2231-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2230-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20
Z-2231-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20
Z-2232-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20
Z-2233-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20

Product code DTQ

K022947Class IIAdvanced Perfusion System 1 (100/120 Volt),advanced Perfusion System 1 (220/240 Volt, Roller Pumps (6, 4 InchTerumo Cardiovascular Systems Corp. / cleared 2003-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)