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