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Health product recall

PHILIPS ULTRASOUND SYSTEMS (2015-04-15)

Starting date:
April 15, 2015
Posting date:
May 8, 2015
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-53263

Recalled Products

A. EPIQ 5 ULTRASOUND SYSTEM
B. EPIQ 7 ULTRASOUND SYSTEM
C. DIAGNOSTIC ULTRASOUND SYSTEM

Reason

Philips has become aware that when the EPIQ 5, EPIQ 7, or Affiniti 70 Ultrasound Systems are set up to 'metric' and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient's Body Surface Area (BSA).

Affected products

A. EPIQ 5 ULTRASOUND SYSTEM

Lot or serial number

Not applicable

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

Not applicable

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

Not applicable

Model or catalog number

AFFINITI 70

Companies
Manufacturer
Philips Ultrasound Inc.
22100 Bothell-Everett Highway
Bothell
98021-8431
Washington
UNITED STATES