Pediatric Vision Scanner Battery Pack Poses Fire Risk
Rebiscan is recalling Blinq Pediatric Vision Scanners (Model BQ830) because the battery pack may vent and catch fire if a cell voltage drops below 2.5V.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a potential fire hazard posed by a defective battery pack. While no injuries or incidents have been reported, the risk of device venting and catching fire under certain conditions qualifies this as a high-risk product recall.
Plain-English summary
Rebiscan, Inc. is recalling the Blinq Pediatric Vision Scanner (Model BQ830), a medical device intended for automated detection of visual axis misalignment in children.
The recall addresses a defect in the device's battery pack. When the voltage of any battery cell drops below 2.5V, the battery pack will not accept a charge. Under these conditions, the battery pack could vent and possibly catch fire, creating a potential fire hazard.
The recall affects 63 units distributed worldwide, including throughout the United States, New Zealand, and Belgium. The affected serial numbers are B-00001-V through B-00105-V, along with additional specific units identified in the recall notification.
The recalled product
- Product
- Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection of misalignment of the visual axes using polarized light. Model Number BQ830
- Manufacturer
- Rebiscan, Inc.
- Hazard
- Affected units
- 63
Distribution
Distributed nationwide across the United States.
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