Device recall
Z-0159-2024: Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and…
FDA device recall · Class II · EMPATICA SRL
Key facts
| Recall number (Z-number) | Z-0159-2024 |
|---|---|
| Recall event | 93215 |
| Product | Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S |
| Product code | POS |
| Recalling firm | EMPATICA SRL |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K181861 |
| FEI number | 3012933969 |
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