Device recall
Z-1393-2018: GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model…
FDA device recall · Class II · GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Key facts
| Recall number (Z-number) | Z-1393-2018 |
|---|---|
| Recall event | 79710 |
| Product | GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. |
| 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 | K030962 |
| 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