Health product recall

SHOEBOX Audiometry Pro (2018-03-26)

Starting date:
March 26, 2018
Posting date:
April 13, 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-66432

Affected products

SHOEBOX Audiometry Pro

Reason

When viewing an old audiogram with a newly installed transducer, an identified software bug deleted the audiogram from the iPad and made the audiogram inaccessible from the data management portal.

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