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Terminated

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

FDA Recall Z-0492-2007 · Posted 2007-02-14

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2006-10-16
Date Terminated2009-07-07
Product Quantity343

Reason for Recall

The pump may lose communication with the central control monitor, causing the monitor to display a service message "System Computer Needs Service" and to become non-operational.

Firm Action

Consignees were notified of the problem via letter dated 11/10/06 and informed that they would be contacted to schedule a service call to install software upgrades. Installation of software upgrades began at customer locations on 10/16/06.

Root Cause

Other

Distribution Pattern

Worldwide distribution --- including USA and countries of Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

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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