Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.

FDA Recall Z-0208-05 · Posted 2004-11-18

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTQ
Date Initiated2003-08-12
Date Terminated2005-09-22

Reason for Recall

The central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.

Firm Action

Service representatives were sent a service bulletin dated 8/12/03 instructing them to correct units in the field bearing serial numbers between 20 and 109.

Root Cause

Other

Distribution Pattern

United States, Belgium, Canada, Dubai, Egypt, Germany, Hong Kong, India, Japan, Korea, Singapore and United Kingdom.

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.

↑