FDA recall Z-3243-2018

Product

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

Reason for recall

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

Distribution

Nationwide Foreign: Mexico, BELGIUM, CANADA, India, Indonesia, Singapore, South Korea , Vietnam

Key facts

Status

Terminated

Initiation date

2018-08-28

Report date

2018-10-03

Termination date

2020-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3243-2018