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Health product recall

Sway Balance Software Application (2014-01-27)

Starting date:
January 27, 2014
Posting date:
April 4, 2014
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-38809

Recalled Products

Sway Balance Software Application

Reason

Version 1.5 of the Sway balance app released on January 22, 2014 was incorrect and displayed artifically high and erroneous Sway balance scores

Affected products

Sway Balance Software Application

Lot or serial number

Version 1.5.0.7

Model or catalog number

Not applicable

Companies
Manufacturer
Sway Medical
8222 East 103 Road Street, Suite 145
Tulsa
74133
Oklahoma
UNITED STATES