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Terminated

Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763

FDA Recall Z-3242-2018 · Posted None

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2018-08-28
Date Terminated2020-04-23
Product Quantity47 units

Reason for Recall

Screws on a Terumo Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system.

Firm Action

Terumo CVS issued letter on 8/2/818 via Fed'X 2 day air to inform users of the problem for the Power Manager boards with unverifiable or out of specification screws, potential hazard and field correction. A Terumo Field Service Representative will contact users to schedule the field correction activities. Terumo CVS Customer Service: 1.800.521.2818, Monday Friday, 8 a.m. 6 p.m. ET

Root Cause

Process control

Distribution Pattern

Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172220Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation · 2017-08-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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