HFA Review (accessory of Humphrey Field Analyzer 3 (HFA3)) (2019-09-06)

Starting date:

September 6, 2019

Posting date:

September 6, 2019

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-70903

Last updated: 2019-09-11

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  Reason
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  Affected products

Affected Products

HFA Review (accessory of Humphrey Field Analyzer 3 (HFA3))

Reason

HFA review software version 1.0.1 which is compatible with HFA 830, 840, 850 and 860 models can possibly cause loss of test results/medical record information leading to a delay in treatment. There is a potential for a delay of treatment that could result in minor deterioration in a patient's vision (loss of less than a line on a visual acuity chart). The HFA review software is an accessory to the HFA instrument and the HFA instrument is not affected.

Affected products