Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual a
Summary
The FDA issued a Class II for Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated d by Rebiscan, Inc.. 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, th.
Details
Source
Device Recall
External ID
Z-0168-2023
Action Date
2022-11-09
Status
Ongoing
Category
device
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
Lot/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
Quantity Affected: 63 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-03
Company
Boston, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 124 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Rebiscan, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Rebiscan, Inc. have FDA actions?
This is the only FDA action we have on record for Rebiscan, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0168-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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