Drug recall
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial…
FDA recall event 64885 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 64885 |
|---|---|
| Recall numbers | Z-1211-2013, Z-1212-2013 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the…, Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard. |
| Initiation date | Mar 28, 2013 |
| Report date | May 8, 2013 |
| Termination date | Oct 25, 2013 |
| 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: