Health product recall

IE33 Diagnostic Ultrasound System-Sector Transducer and EPIQ Ultrasound Transducers (2019-09-06)

Starting date:
September 6, 2019
Posting date:
September 20, 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-71017

Last updated: 2019-09-20

Affected Products

  1. IE33 Diagnostic Ultrasound System-Sector Transducer
  2. EPIQ Ultrasound Transducers

Reason

A small number of S7-3T and S8-3T TEE transducers were not properly programmed during manufacturing, as a result the system is unable to correctly measure the temperature on the distal tip of the transducer. EPIQ and IE33 systems will show the transducer temperature (TEE T) as  0.0°c>

Affected products

  1. IE33 Diagnostic Ultrasound System-Sector Transducer

Lot or serial number

Not applicable.

Model or catalog number

S8-3T

Companies
Manufacturer
Philips Ultrasound Inc.
22100 Bothell-Everett Highway
Bothell
98021-8431
Washington
UNITED STATES

B. EPIQ Ultrasound Transducers

Lot or serial number

Not applicable.

Model or catalog number

S7-3T
S8-3T

Companies
Manufacturer
Philips Ultrasound Inc.
22100 Bothell-Everett Highway
Bothell
98021-8431
Washington
UNITED STATES