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U.S. Department of Health and Human Services

Class 2 Device Recall Rebion

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  Class 2 Device Recall Rebion see related information
Date Initiated by Firm October 03, 2022
Date Posted November 01, 2022
Recall Status1 Open3, Classified
Recall Number Z-0168-2023
Recall Event ID 90968
Product Classification Strabismus detection device - Product Code PMW
Product Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light.
Model Number BQ830
Code Information 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
Recalling Firm/
Manufacturer		 Rebiscan, Inc.
100 Cambridge St Fl 14
Boston MA 02114-2509
For Additional Information Contact SAME
857-600-0982
Manufacturer 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
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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