Device recall
Z-2326-2024: Decompression Table Model E9011. This device applies cervical and/or lumbar…
FDA device recall · Class II · Pivotal Health Solutions, Inc.
Key facts
| Recall number (Z-number) | Z-2326-2024 |
|---|---|
| Recall event | 94815 |
| Product | Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment. |
| Product code | ITH |
| Recalling firm | Pivotal Health Solutions, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K101889 |
| FEI number | 3007278668 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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