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 balloon is placed.
Check against the official notice below — it lists the full affected range.
The Obalon Balloon System with Model 4300 Touch Dispenser (Software version 02.00.00.0076) has been recalled due to a touchscreen calibration issue. During initial setup, battery replacement, or when the touchscreen is pressed while the device powers on before balloon administration, the touchscreen can lose calibration and become unresponsive, preventing balloon inflation from being initiated. The recall affects 45 units nationwide, including systems distributed to Virginia, New York, Georgia, Texas, Tennessee, Oregon, Florida, Louisiana, Connecticut, and New Jersey.
The recalled devices are identified by UDI 00859810006104 and include specific serial numbers ranging from 0076 to 0133. The source document does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated.
Reason for recall: During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscreen is pressed when the device is powered on in preparation for a balloon administration. As a result, the touchscreen can become unresponsive and balloon inflation cannot be initiated. Distribution: US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ. Quantity: 45 units Lot/code info: 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, 0095, 0097, 0099, 0100, 0101, 0102, 0103, 0104, 0106, 0107, 0109, 0111, 0112, 0113, 0115, 0118, 0119, 0120, 0121, 0122, 0125, 0126, 0127, 0129, 0130, 0133.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.