Device recall
Z-1728-2009: Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4…
FDA device recall · Class II · Hologic, Inc.
Key facts
| Recall number (Z-number) | Z-1728-2009 |
|---|---|
| Recall event | 51692 |
| Product | Hologic Delphi series Bone Densitometer Software versions 12.6, 2.3., or 2.4 Indicated for the estimation of bone mineral density (BMD), comparison of measurable variables obtained from a given QDR scan to a database of reference values, the estimation of fracture risk, vertebral deformity… |
| Product code | KGI |
| Recalling firm | Hologic, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2010 |
| 510(k) numbers | K072847 |
| FEI number | 1221300 |
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