Device recall
Z-0684-2025: Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive…
FDA device recall · Class II · Spacelabs Healthcare, Ltd.
Key facts
| Recall number (Z-number) | Z-0684-2025 |
|---|---|
| Recall event | 95786 |
| Product | Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram. |
| Product code | MWJ |
| Recalling firm | Spacelabs Healthcare, Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K211651 |
| 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