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Terminated

Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046.

FDA Recall Z-0381-2007 · Posted 2007-02-01

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2006-11-08
Date Terminated2007-06-11
Product Quantity35

Reason for Recall

Following installation of software version 1.30 in October 2006, the firm confirmed a complaint that the new software caused a discrepancy in the pump speed calculation and caused the pump to stop during clinical use and a ''connect motor'' message to be displayed.

Firm Action

Customers were notified by phone, fax, email or by a Terumo representative of these problems between 11/08/06 and 11/13/06 and instructed to not use the unit until new software had been installed. All version 1.30 software was replaced and version 1.40 installed prior to 12/4/06.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022947ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCHTerumo Cardiovascular Systems Corp. · 2003-03-20

Official Source

View FDA Recall →

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

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