Health product recall

EPIQ ULTRASOUND SYSTEM (2021-01-13)

Starting date:
January 13, 2021
Posting date:
January 29, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-74871



Last updated:
2021-01-29

Affected Products

A. EPIQ 5 ULTRASOUND SYSTEM

B. EPIQ 7 ULTRASOUND SYSTEM

C. EPIQ DIAGNOSTIC ULTRASOUND SYSTEM

Reason

Philips recently discovered an issue associated with EPIC ultrasound systems where the control panel arm assembly could have missing or loose screws. In these cases, if undue force, pressure or weight is applied, the control panel mechanism can fail and break off. We are aware of three instances where the control panel arm with missing/loose screws broke and collapsed, one of them causing a minor injury to the operator.

Affected products

A. EPIQ 5 ULTRASOUND SYSTEM

Lot or serial number

All lots. 

Model or catalog number

EPIQ 5

Companies
Manufacturer

Philips Ultrasound Inc.

22100 Bothell-Everett Highway

Bothell

98021-8431

Washington

UNITED STATES


B. 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


C. 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