Health product recall

Electronic Gas Blender (2019-04-27)

Starting date:
April 27, 2019
Posting date:
May 22, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70003

Last updated: 2019-05-22

Affected Products

Electronic Gas Blender

Reason

Terumo Cardiovascular Systems (Terumo CVS) is initiating a voluntary field correction of the Electronic Patient Gas System (EPGS) internal flowmeter included with Terumo System 1 devices because the gas flow rate output of the EPGS, which is reported in the Terumo System 1 Central Control Monitor (CCM), may be inaccurate. Through internal investigation, Terumo CVS identified that the cause of the potential inaccuracies is a defect in the EPGS internal flowmeter. Additionally, while the user may notice that the intended gas flow setpoint (slider) and the delivered gas flow reading on the CCM display do not match, there may be no other notification of the fault condition on the CCM.

Affected products

Electronic Gas Blender

Lot or serial number

All lots.

Model or catalog number

801188
801188R

Companies
Manufacturer

Terumo Cardiovascular Systems Corp.

6200 Jackson Road

Ann Arbor

48103

Michigan

UNITED STATES