Device recall
Z-0685-2025: Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive…
FDA device recall · Class II · Spacelabs Healthcare, Ltd.
Key facts
| Recall number (Z-number) | Z-0685-2025 |
|---|---|
| Recall event | 95786 |
| Product | Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram. |
| Product code | MWJ |
| Recalling firm | Spacelabs Healthcare, Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212317 |
| FEI number | 3002807992 |
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