Device recall
Z-0601-2010: Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE…
FDA device recall · Class II · Ge Healthcare
Key facts
| Recall number (Z-number) | Z-0601-2010 |
|---|---|
| Recall event | 53692 |
| Product | Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD |
| Product code | KGI |
| Recalling firm | Ge Healthcare |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 31, 2011 |
| FEI number | 3005860720 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database