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Recall Observatory FDA recall evidence

Device product

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

Z-0168-2023

October 03, 2022

Class II

Product summary

Firm
Rebiscan, Inc.
Event
Event 90968
Status
Ongoing
Classification
Class II
Quantity
63 units
Official record key
device-enforcement:Z-0168-2023

Official wording

Reason: 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

Code information: UDI: 008648160004 Serial Numbers: B-00001-V thru B-00105-V B-00021 B-00022 B-00036 B-00052 B-00054 thru B-00060 B-00062 thru B-00065 B-00070 B-00071 B-00075 thru B-00077 B-00079 B-00082 thru B-00098 B-00100 thru B-00104 B-00106 B-00109 B-00111 thru B-00113

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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