Recall Z-1805-2020 ยท LTI Implant, Intragastric For Morbid Obesity
Obalon Therapeutics Inc
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.
| Date | May 23, 2019 |
| Status | Completed |
| 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. |
| Root cause | Software design |
| Action | To ensure that customers would receive the recall notification bulletin, and to ensure that the bulletin would not be lost in an email inbox, customers were contacted by telephone beginning on 5/23/2019 to notify them that they would be receiving an email containing the notification bulletin. These emails, first sent on 5/23/2019, contained Customer Bulletin no. LIT-7410-0025-01. The bulletin notified customers of the unintended functionality of the touchscreen during power-up, provided instructions to contact Obalon Customer Service immediately it this situation occurs, and contained updated |
| Quantity | 45 units |
| Distribution | US Nationwide distribution including the states of VA, NY, GA, TX, TN, OR, FL, LA, CT, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.