Device recall
Z-0064-04: ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with…
FDA device recall · Class II · Acist Medical Systems
Key facts
| Recall number (Z-number) | Z-0064-04 |
|---|---|
| Recall event | 27388 |
| Product | ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units) |
| Product code | DXT |
| Recalling firm | Acist Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 23, 2005 |
| 510(k) numbers | K984231 |
| FEI number | 3001726808 |
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