Drug recall
ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH…
FDA recall event 83813 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 83813 |
|---|---|
| Recall numbers | Z-0175-2020 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | May not provide visual and/or audible alarms at the CARESCAPE Central Station or Clinical Information Center monitor for ECG arrhythmias, ECG LEADS FAIL or Pulse Oximetry (SpO2) under certain… |
| Initiation date | Aug 30, 2019 |
| Report date | Oct 30, 2019 |
| 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: