Drug recall
OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging…
FDA recall event 76033 · Class II · GE OEC Medical Systems, Inc
Key facts
| Event ID | 76033 |
|---|---|
| Recall numbers | Z-0973-2017, Z-0974-2017, Z-0975-2017 |
| Recalling firm | GE OEC Medical Systems, Inc |
| Product type | Devices |
| Products | OEC 9800. MDL Numbers: D222250, D141598 The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical…, OEC MiniView 6800. MDL Number: D002533 The OEC MiniView 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited…, The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GE Healthcare Surgery announces a voluntary field action for the OEC MiniView 6800, OEC 9900 Elite, and OEC 9800 because the workstation power cable assembly can result in intermittent power cord… |
| Initiation date | Dec 19, 2016 |
| Report date | Jan 18, 2017 |
| Termination date | Aug 22, 2017 |
| City | Salt Lake City |
| State | UT |
| Country | United States |
| FEI number | 1720753 |
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: