Health product recall

DIAGNOSTIC ULTRASOUND SYSTEMS (2020-11-03)

Starting date:
November 3, 2020
Posting date:
November 20, 2020
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-74351

Last updated:
2020-11-19

Affected Products

A. EPIQ 5 ULTRASOUND SYSTEM

B. EPIQ 7 ULTRASOUND SYSTEM

C. DIAGNOSTIC ULTRASOUND SYSTEM

D. AFFINITY 30 DIAGNOSTIC ULTRASOUND SYSTEM

E. AFFINITY 70 DIAGNOSTIC ULTRASOUND SYSTEM

Reason

Philips has determined that with certain uncommon workflows there is potential for incorrect patient data to be displayed and saved into an exam.

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. DIAGNOSTIC ULTRASOUND SYSTEM

Lot or serial number

All lots.

Model or catalog number

AFFINITI 50
AFFINITI 70

Companies
Manufacturer

Philips Ultrasound Inc.

22100 Bothell-Everett Highway

Bothell

98021-8431

Washington

UNITED STATES

D. AFFINITY 30 DIAGNOSTIC ULTRASOUND SYSTEM

Lot or serial number

All lots.

Model or catalog number

989605457591

Companies
Manufacturer

Philips Ultrasound Inc.

22100 Bothell-Everett Highway

Bothell

98021-8431

Washington

UNITED STATES

E. AFFINITY 70 DIAGNOSTIC ULTRASOUND SYSTEM

Lot or serial number

All lots.

Model or catalog number

AFFINITI 70

Companies
Manufacturer

Philips Ultrasound Inc.

22100 Bothell-Everett Highway

Bothell

98021-8431

Washington

UNITED STATES