ImageDrive Clinical (2020-02-26)

Starting date:

February 26, 2020

Posting date:

April 16, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-72751

Last updated: 2020-04-16

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  Reason
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  Affected products

Affected Products

ImageDrive Clinical

Reason

A software defect was discovered when investigating a customer complaint submitted on 2020-02-04. While the likelihood of potential serious health consequences is remote, the use of the defective software associated could result in misdiagnosis, potentially causing significant indirect harm necessitating medical intervention that is serious but temporary.

Affected products