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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