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SPACELABS HEALTHCARE (WASHINGTON), INC · Model 90481 · UDI-DI 10841522101892
1
510(k) clearances
33,398
Adverse events (508 deaths)
82
Recalls
118
Facilities
Description
ADAPTER,EEG LEADWIRES,4 LEAD
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-26 | Spacelabs Healthcare, Inc. | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). |
| 2026-02-27 | Spacelabs Healthcare, Inc. | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurem |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
| 2025-10-31 | Philips North America Llc | Potential issue where the IntelliVue monitors did not alarm. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.