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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect results in a device malfunction (inability to inflate) rather than a direct physical injury or contamination hazard.
Plain-English summary
Obalon Therapeutics Inc is recalling 45 units of the Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen. The recall affects devices with software version 02.00.00.0076 and specific serial numbers listed in the agency notice. The product is intended to be used as an adjunct to a moderate intensity diet and behavior modification program.
The recall is due to a defect where the touch dispenser touchscreen can inadvertently lose calibration during initial set-up, battery replacement, or if pressed when the device is powered on. This issue can cause the touchscreen to become unresponsive, which prevents the initiation of balloon inflation.
The affected units were distributed nationwide in the United States, including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ. Users of the affected devices should contact Obalon Therapeutics Inc for further instructions on how to proceed.
The recalled product
- 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
- Manufacturer
- Obalon Therapeutics Inc
- Hazard
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- ObalonR Balloon System with Navigation and Touch. UDI: 00859810006104
- Model No.: Model 4300 Touch Dispenser
- Software version 02.00.00.0076. Serial Numbers: 0097
- 0076
- 0077
- 0078
- 0079
- 0080
- 0082
- 0083
- 0084
- 0085
- 0086
- 0087 0088
- 0089
- 0090
- 0091
- 0092
- 0093
- 0094
Distribution
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