Drug recall
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
FDA recall event 83220 · Class II · Spacelabs Healthcare, Inc.
Key facts
| Event ID | 83220 |
|---|---|
| Recall numbers | Z-2035-2019 |
| Recalling firm | Spacelabs Healthcare, Inc. |
| Product type | Devices |
| Products | Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. |
| Initiation date | Jan 28, 2019 |
| Report date | Jul 31, 2019 |
| Termination date | Feb 24, 2022 |
| City | Snoqualmie |
| State | WA |
| Country | United States |
| FEI number | 3010157426 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: