Medical device recalls Moderate risk

Rebiscan product recalled over fire hazard

Recall date
October 3, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Rebiscan, Inc. recalls Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual…
Recall number
Z-0168-2023
FDA classification
Class II
Brand / firm
Rebiscan, Inc.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.

Why it was recalled

Unable to charge the battery pack- battery packs will allow the batteries to be charged if the voltage of any cell is below 2.5V. When this occurs, the battery pack will not accept the charge, could vent and possibly catch fire

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830

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