medical Class II Updated 2018-10-03

Terumo Cardiovascular Systems Corporation recalls Terumo 220/240V AC, Advanced Perfusion System Platform (APS)

Recalled Product

Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 1522 1523 1524 1525 1528 1530 1526 1527 1532 1544 Spare Parts: 870509 ASSEMBLY POWER MANAGER POD APS S/N: 03097 03099 03100 03101 03113 03114 03115 03143 03155 03167 03264
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