Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use

FDA device recall Z-2010-2012 · posted 2012-07-13 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The fai

Action taken

Terumo sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 21, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. CUSTOMER INSTRUCTIONS 1. Review this Medical Device Recall notice. 2. Assure that all users are aware of this notice. 3. Confirm receipt of this communication by faxing, or emailing the attached Customer Response Form to the fax number/ email address indicated on the form. Terumo CVS Customer Service-1-800-521-2818 Fax-1-800-292-6551. Customer Service Hours: Monday - Friday, 8 AM - 6 PM EST

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DTQ

Quantity affected

648 units

Distribution

Worldwide Distribution-USA (nationwide) including the states of , AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR

Date initiated

2012-06-21

Date posted

2012-07-13

Date terminated

2013-06-10

Location

Ann Arbor, MI

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