Health product recall

SHOEBOX Audiometry Pro (2018-11-06)

Starting date:
November 6, 2018
Posting date:
November 28, 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-68440

Affected products

SHOEBOX Audiometry Pro

Reason

Customer reported a bug where in rare instances there is a discrepancy between system-volume level setting and presented volume.

Affected products

SHOEBOX Audiometry Pro

Lot or serial number

All lots.

Model or catalog number
  • SB004
Companies
Manufacturer

CLEARWATER CLINICAL LTD.

1306 WELLINGTON ST. W, SUITE 501

Ottawa

K1Y 3B2

CANADA