FDA Medical Device Recalls (openFDA)
Rebiscan, Inc.: Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
- Recall number
- Z-0168-2023
- 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
- Status
- Open, Classified
- Initiated
- 2022-10-03
- Posted
- 2022-11-01
- Terminated
- not on file
- 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
- 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
- 63 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of New Zealand, Belgium.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PMW
- Firm FEI
- 3014522421
- Firm city
- Boston
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28