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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-0312-2007 · Posted 2006-12-27

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2004-05-01
Date Terminated2007-02-01
Product Quantity55

Reason for Recall

The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.

Firm Action

U.S. consignees were visited and new software installed between May 2004 and November 2005. Currently, approximately 50% of exported units have been upgraded.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Belgium, Canada, China, Egypt, Germany, India, Indonesia, Japan, Malaysia, Pakistan, Republic of China, Singapore, South Africa, South Korea and United Arab Emirates.

Official Source

View FDA Recall →

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

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