Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
FDA Recall Z-0168-2023 · Posted 2022-11-01
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Recalling FirmRebiscan, Inc.
Recall StatusOpen, Classified
Product CodePMW
Date Initiated2022-10-03
Product Quantity63 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
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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