07

May

2020

Recall – Stomach balloon system touchscreen becomes unresponsive

recall, softwareerror

0

Company: Obalon Therapeutics Inc
Date of Enforcement Report: 5/7/2020
Class II

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.

Recall Number: Z-1805-2020

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/MANUFACTURER

Obalon Therapeutics Inc. on 5/23/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

45 units

DISTRIBUTION

US Nationwide

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