FDA Enforcement
Class II
Ongoing
Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
Recall: Z-0168-2023
·
Reported November 9, 2022
Enforcement
- Recall Number
- Z-0168-2023
- Event ID
- 90968
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Rebiscan, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 9, 2022
- Initiation Date
- October 3, 2022
- Classification Date
- November 1, 2022
- Address
- 100 Cambridge St Fl 14, N/A, Boston, MA, 02114-2509, United States
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
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 Info
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
Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.
Quantity
63 units