Health product recall

EPIQ ULTRASOUND SYSTEM (2020-12-24)

Starting date:
December 24, 2020
Posting date:
January 15, 2021
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-74759

Last updated:
2021-01-15

Affected Products 

A. EPIQ 7 ULTRASOUND SYSTEM
B. EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

Reason

Philips recently discovered an issue associated with the EPIC image boost with xplane and color flow or doppler while using the X8-2T tee transducer. If image boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if image boost is enabled, both CW and PW doppler traces will not accurately represent the fluid flow. The nature of defectiveness and root cause of the issue is a software fault/defect.

Affected products

A. EPIQ 7 ULTRASOUND SYSTEM

Lot or serial number

All lots. 

Model or catalog number

EPIQ 7

Companies
Manufacturer

Philips Ultrasound Inc.

22100 Bothell-Everett Highway

Bothell

98021-8431

Washington

UNITED STATES

B. EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

Lot or serial number

All lots. 

Model or catalog number

EPIQ

Companies
Manufacturer

Philips Ultrasound Inc.

22100 Bothell-Everett Highway

Bothell

98021-8431

Washington

UNITED STATES