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