ClearanceBrief
Recall Z-2009-2012 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass

Terumo Cardiovascular Systems Corporation

Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

DateJul 13, 2012 (initiated Jun 21, 2012)
StatusTerminated
ReasonTerumo 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
Root causeNonconforming Material/Component
ActionTerumo 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
Quantity992 units
DistributionWorldwide 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, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, CAN
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022947ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
Terumo Cardiovascular Systems Corp., Mar 20, 2003