EPIQ 5 ULTRASOUND SYSTEM (2021-08-05)
- Starting date:
- August 5, 2021
- Posting date:
- August 19, 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-76273
Last updated:
2021-08-19
Affected Products
- EPIQ 5 ULTRASOUND SYSTEM
- EPIQ 7 ULTRASOUND SYSTEM
- DIAGNOSTIC ULTRASOUND SYSTEM
- AFFINITI 30 DIAGNOSTIC ULTRASOUND SYSTEM
- EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Reason
Due to a software defect, when reviewing or adjusting xPlane exam results, there is a potential for EPIQ & EPIQ Affiniti Ultrasound systems to become unresponsive (Lock-up) preventing users from continuing clinical use. The ultrasound system provides an error notification including method to restart and bring system back to normal use.
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. AFFINITI 30 DIAGNOSTIC ULTRASOUND SYSTEM
Lot or serial number
All lots.
Model or catalog number
9.89605E+11
Companies
- Manufacturer
-
Philips Ultrasound Inc.
22100 Bothell-Everett Highway
Bothell
98021-8431
Washington
UNITED STATES
E. 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