The Recall Desk
HighFDA (Devices)·Z-0168-2023·Announced 2022-11-09

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.

What this means for you

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.
Category
Medical Device — Pediatric Vision Screening
Hazard
Affected units
63

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · fire

See all →