Drug recall
CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
FDA recall event 88106 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 88106 |
|---|---|
| Recall numbers | Z-2139-2021 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | CARESCAPE PDM-Masimo SpO2. Physiological data monitor. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down. |
| Initiation date | May 21, 2021 |
| Report date | Aug 4, 2021 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
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: