Health product recall

Terumo Advanced Perfusion System 1 Power Manager Board (2018-11-13)

Starting date:
November 13, 2018
Posting date:
January 8, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68674

Affected products

Terumo Advanced Perfusion System 1 Power Manager Board

Reason

During internal testing, Terumo CVS identified that 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 is not properly torqued can loosen over time resulting in an electrical short.

Affected products

Terumo Advanced Perfusion System 1 Power Manager Board

Lot or serial number

1559,1567

Model or catalog number
  • 801763
Companies
Manufacturer

Terumo Cardiovascular Systems Corp.

6200 Jackson Road

Ann Arbor

48103

Michigan

UNITED STATES