Z-0168-2023Class II

Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of...

Name: Z-0168-2023 Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of...
Creator: Rebiscan, Inc.
Published: 2022-10-03
License: https://open.fda.gov/license/

Rebiscan, Inc. / initiated 2022-10-03 / Open, Classified / root cause: design

FDA source

Rebiscan, Inc. began a recall of Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number... on 2022-10-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0168-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-03
Posted: 2022-11-01
Recalling firm: Rebiscan, Inc.
Product: Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
Product code: PMW Strabismus Detection Device
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
Root cause tag: design
FDA root cause: Device Design
Action: Rebion issued Urgent Medical Device Removal letter on 10/3/22 via Certified Mail. Letter states reason for recall, health risk and action to take: 1. Return the provided response form acknowledge receipt of this communication. 2. Stop using the device 3. Return the device, along with its power cord and carry case, to Rebion In the event that you have noticed abnormal device behavior related to charging, battery life, or excessive heat while operating the device, then please contact us immediately PLANNED ACTION TO BE TAKEN BY REBION 1. Rebion plans to evaluate and repair each device at no charge. 2. Provide each customer with a postage paid shipping label 3. Upon receipt of the device, Rebion will determine whether the battery pack is affected. 4. Affected battery packs will be replaced. 5. The device will be returned to the customer. FURTHER INFORMATION AND SUPPORT If you need further information or support for this issue, contact your Rebion representative or contact Rebion Customer Service at 877-499-9966.
Quantity in commerce: 63 units
Distribution: Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0168-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0168-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-11-01

Product code PMW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)