Drug recall
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
FDA recall event 86531 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 86531 |
|---|---|
| Recall numbers | Z-0311-2021, Z-0312-2021, Z-0313-2021, Z-0314-2021, Z-0315-2021, Z-0316-2021, Z-0317-2021 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only., Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability…, Flow Sensor Service Part, Catalog 2087640-001-S, Flow Sensor Service Part, Catalog 2089610-001-S, Flow Sensor Service Part, Catalog 2096513-001-S and 2 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Flow sensors could have damaged tubes in the form of small punctures or cuts. |
| Initiation date | Sep 17, 2020 |
| Report date | Nov 11, 2020 |
| 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: