EPIQ ULTRASOUND SYSTEM (2020-12-24)
- Starting date:
- December 24, 2020
- Posting date:
- January 15, 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-74759
Last updated: 2021-01-15
Affected Products
A. EPIQ 7 ULTRASOUND SYSTEM
B. EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
Reason
Philips recently discovered an issue associated with the EPIC image boost with xplane and color flow or doppler while using the X8-2T tee transducer. If image boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if image boost is enabled, both CW and PW doppler traces will not accurately represent the fluid flow. The nature of defectiveness and root cause of the issue is a software fault/defect.
Affected products
A. 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
B. 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