Health product recall

SHOEBOX Audiometry Pro (2018-07-20)

Starting date:
July 20, 2018
Posting date:
August 17, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67464

Affected products

SHOEBOX Audiometry Pro

Reason

Customer reported bug where speech reception results were 20dB below anticipated results during speech reception testing (SRT) in SHOEBOX Pro.

Affected products

SHOEBOX Audiometry Pro

Lot or serial number

ALL RUNNING VERSION 5.0.2

Model or catalog number

SB004

Companies
Manufacturer

CLEARWATER CLINICAL LTD.

1306 WELLINGTON ST. W, SUITE 501

Ottawa

K1Y 3B2

CANADA