Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the

FDA device recall Z-2230-2012 · posted 2012-08-21 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

DTQ

Quantity affected

579 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,

Date initiated

2012-07-26

Date posted

2012-08-21

Date terminated

2014-06-27

Location

Ann Arbor, MI

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