Recall Z-1805-2020— Obalon Therapeutics Inc
Class II · Completed
Class II FDA medical device recall by Obalon Therapeutics Inc, initiated 2019-05-23. FDA's recall record names no specific 510(k) clearance for this event. 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 balloon is placed. The Obalon Balloons are administered using the Navigation System.. Reason: 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..
- Recalling firm
- Obalon Therapeutics Inc
- Classification
- Class II
- Status
- Completed
- Initiated
- 2019-05-23
- Firm location
- Carlsbad, CA, United States
Product description
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. The Obalon Balloons are administered using the Navigation System.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.