Spacelabs Healthcare, Ltd. Recall: Eclipse PRO REF 98700 The Spacelabs model 98700 is a po
Spacelabs Healthcare, Ltd. Recall: Eclipse PRO REF 98700 The Spacelabs model 98700 is a po is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Spacelabs Healthcare, Ltd.; Product: Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record
| Recalling firm | Spacelabs Healthcare, Ltd. |
|---|---|
| Product | Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram. |
| Reason for recall | Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | U.S.: AR, CA, CO, DE, FL, FA, LA, MA, MI, MN, MT, NC, NE, NU OH, OR, PA, Puerto Rico, TN, TX, UT, VA, WA, and WI. O.U.S.: Argentina Denmark Kuwait Serbia Australia Dominican Republic Lebanon Singapore Austria Ecuador Lithuania Spain Belgium El Salvador Martinique Sweden Benin France Mexico Switzerla |
| Recall initiated | 20241125 |
| Recall number | Z-0684-2025 |
| Category | device |
| Country | United Kingdom |
$29/mo
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