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