Device recall
Z-1558-2022: AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM…
FDA device recall · Class III · Siemens Medical Solutions USA, Inc
Key facts
| Recall number (Z-number) | Z-1558-2022 |
|---|---|
| Recall event | 90632 |
| Product | AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a… |
| Product code | DQK |
| Recalling firm | Siemens Medical Solutions USA, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 7, 2024 |
| 510(k) numbers | K150493 |
| FEI number | 2240869 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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