Drug recall
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator…
FDA recall event 63761 · Class I · GE Healthcare, LLC
Key facts
| Event ID | 63761 |
|---|---|
| Recall numbers | Z-0748-2013, Z-0749-2013 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic…, Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. |
| Initiation date | Oct 15, 2012 |
| Report date | Feb 20, 2013 |
| Termination date | Jan 18, 2017 |
| 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: