FDA recall Z-0168-2023

Product

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.

Key facts

Status

Ongoing

Initiation date

2022-10-03

Report date

2022-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boston, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0168-2023