Health product recall

EPIC ULTRASOUND SYSTEM (2021-07-23)

Starting date:
July 23, 2021
Posting date:
August 6, 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-76169

Last updated:
2021-08-06

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 the swivel mechanism of the control panel assembly for the device EPIQ Ultrasound Systems where the control panel arm assembly could swivel. Mechanism of the control panel assembly for the EPIQ device includes a plastic bushing, which is a part designed to prevent small side-to-side movements (rattle) of the Control Panel when the swivel mechanism is in the locked position. The bushing appears to be backed out (or stick out) of the hole it is retained within, preventing the swivel mechanism from locking properly. This causes the entire control panel and monitor to swivel freely.

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