Device recall
Z-1571-2008: EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software…
FDA device recall · Class III · Hitachi Medical Systems America Inc
Key facts
| Recall number (Z-number) | Z-1571-2008 |
|---|---|
| Recall event | 47253 |
| Product | EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information. |
| Product code | LHN |
| Recalling firm | Hitachi Medical Systems America Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 24, 2012 |
| 510(k) numbers | K0601608 |
| FEI number | 1528028 |
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