Z-0168-2023 Class II Ongoing

Recalled by Rebiscan, Inc. — Boston, MA

Recall Details

Product Type
Devices
Report Date
November 9, 2022
Initiation Date
October 3, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
63 units

Product Description

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 Pattern

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

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