Device recall
Z-1805-2020: Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software…
FDA device recall · Class II · Obalon Therapeutics Inc
Key facts
| Recall number (Z-number) | Z-1805-2020 |
|---|---|
| Recall event | 85050 |
| 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… |
| Product code | LTI |
| Recalling firm | Obalon Therapeutics Inc |
| Recall class | Class II |
| Status | Completed |
| PMA numbers | P160001, P160001S007, P160001S020 |
| FEI number | 3013508647 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database