Drug recall
Infant Warmer System (IWS)
FDA recall event 77287 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 77287 |
|---|---|
| Recall numbers | Z-2323-2017 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | Infant Warmer System (IWS) |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall… |
| Initiation date | May 5, 2017 |
| Report date | Jun 21, 2017 |
| Termination date | Jul 12, 2018 |
| 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: