Spot Vision Screener (2018-06-18)

Starting date:

June 6, 2018

Posting date:

October 11, 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-71223

Last updated: 2019-10-11

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  Reason
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  Affected products

Affected Products

Spot Vision Screener

Reason

If the device is not used or charged every five months, the coin cell battery that maintains the system clock may become depleted.  This may cause the patient age to be calculated incorrectly. An incorrect patient age could result in an incorrect (either under or over) referral recommendation.

Affected products