Drug recall
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support…
FDA recall event 73617 · Class II · GE Medical Systems, LLC
Key facts
| Event ID | 73617 |
|---|---|
| Recall numbers | Z-1562-2016 |
| Recalling firm | GE Medical Systems, LLC |
| Product type | Devices |
| Products | GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult). |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The vacuum suction tubing could be kinked within the machine resulting in suction less than the 20 lpm required by ISO 10079-3. This could result in inadequate suction performance to clear the airway… |
| Initiation date | Mar 15, 2016 |
| Report date | May 4, 2016 |
| Termination date | Nov 7, 2016 |
| 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: