Obalon Balloon System Recalled Due to Touchscreen Calibration Issues
Obalon Therapeutics is recalling 45 Obalon Balloon Systems because the touchscreen may lose calibration, preventing balloon inflation.
- Product
- Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first
- Category
- Medical Device
- Distribution
- Distributed nationwide