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Terminated

Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).

FDA Recall Z-0446-2009 · Posted 2008-12-29

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDTQ
Date Initiated2008-04-17
Date Terminated2009-07-07
Product Quantity161

Reason for Recall

The power supply may fail to charge the batteries due to various hardware malfunctions.

Firm Action

Terumo notified U.S. consignees via Urgent Medical Device Correction: Safety Advisory recall letter dated 4/17/08 and international consignees were notified via email on 4/24/08 informing them of the potential problem.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution: USA, Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong, Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates, and Viet Nam.

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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