FDAClass IINovember 9, 2022

Blinq Pediatric Vision Scanner-Pediatric Vision recall

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

Why was Blinq Pediatric Vision Scanner-Pediatric Vision recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light.…
Recalling firm
Rebiscan, Inc.
Quantity
63 units
Distribution
Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.
Recall date
November 9, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls