System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorpo

FDA device recall Z-2021-2012 · posted 2012-07-17 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

Reason for recall

Terumo Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or

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. The letter instructs customers to place the addendum in the Operator's Manual for Terumo System 1, at the beginning of the Central Control Module Section. Additionally, a Customer Response Form was attached for customers to complete and return to the firm. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this notice.

Root cause

Process control

Status

Terminated

Product code

DTQ

Quantity affected

648

Distribution

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

Date initiated

2012-06-21

Date posted

2012-07-17

Date terminated

2013-03-26

Location

Ann Arbor, MI

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