Device recall
Z-1395-2018: GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431…
FDA device recall · Class II · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Key facts
| Recall number (Z-number) | Z-1395-2018 |
|---|---|
| Recall event | 79710 |
| Product | GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal… |
| Product code | KGI |
| Recalling firm | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2020 |
| 510(k) numbers | K982267 |
| FEI number | 2183066 |
At a glance
- 1–9 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