Health product recall

EPIQ 5 and EPIQ 7 Ultrasound Systems, Diagnostic Ultrasound System (2019-05-01)

Starting date:
May 1, 2019
Posting date:
May 10, 2019
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-69898



Last updated: 2019-05-10

Affected Products

A. EPIQ 5 Ultrasound System

B. EPIQ 7 Ultrasound System

C. Diagnostic Ultrasound System

Reason

When the user uses the edit functionality on the patient data entry (PDE) screen, there is the potential that one patient's images could get unexpectedly moved into another patient's folder.

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