Jan

2007

Class II Terumo Cardiovascular Systems Corp.

Company:Terumo Cardiovascular Systems Corp
Date of Enforcement Report:1/5/2007
Class:ll

PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker),
50/60 Hz (20A power source required); Models 801763, Recall # Z-0314-2007;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker),
50/60 Hz (10A power source required); Model 801764.
(Not distributed within the United States), Recall # Z-0315-2007

REASON
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.

CODE
a) Serial numbers 0093 and 0104 through 0114;
b) Serial numbers 0040 through 0044

RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by visits between May 2004 and November 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
17 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Class II Terumo Cardiovascular Systems Corp.

Amy Sellers

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