FDA-Device2018-10-03Class II
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
Terumo Cardiovascular Systems Corporation
Hazard
Screws on a Terumo¿ Advanced Perfusion System 1 Power Manager Board (the base unit circuit board) were not torqued to specification. It is possible that a screw which has not been properly torqued can go undetected during manufacturing testing and may loosen over time, resulting in the potential for an electrical short in the system
Sold states
Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam
Affected count
10 units
Manufactured in
6200 Jackson Rd, Ann Arbor, MI, United States
Products
Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3243-2018Don't want to check this manually?
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