Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use

FDA device recall Z-1958-2012 · posted 2012-07-06 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusion System 1 losing partial or full functionality. Symptoms that have been associated with a malfunctioning CCM include: full or partial loss of display, loss of control functions; inability to distinguish various status, alert, alarm conditions, the inability to operate the touch screen, or the CCM

Action taken

The firm, TERUMO, sent an "URGENT MEDICAL DEVICE RECALL" notice dated June 22, 2012 and addendum to the Operator's Manual via Federal Express to its customers. The letter described the product, problem and actions to be taken. The notice states to the customers "Please note that we are not recommending that you stop using your Central Control Monitor". The customers were instructed to review the Medical Device Recall notice; assure that all users are aware of this notice; place the Addendum at the beginning of the Central Control Monitor Section (page 4-1) of the Operator's Manual and complete and return the attached Customer Response Form to the fax number indicated on the form. If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818; customer service hours are from Monday-Friday, 8 AM - 6 PM ET.

Root cause

Device Design

Status

Terminated

Product code

DTQ

Quantity affected

648 units

Distribution

Worldwide distribution: USA (nationwide) and countries including: Argentina, Belgium, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, In

Date initiated

2012-06-22

Date posted

2012-07-06

Date terminated

2013-03-06

Location

Ann Arbor, MI

Related 510(k) clearances