Device recall
Z-0643-2009: ACIST CVi Angiographic Injection System with Interface Cable for Toshiba…
FDA device recall · Class II · Acist Medical Systems
Key facts
| Recall number (Z-number) | Z-0643-2009 |
|---|---|
| Recall event | 50501 |
| Product | ACIST CVi Angiographic Injection System with Interface Cable for Toshiba Infinix-i cardiovascular X-ray system, Part Number 700318-002. The ACIST injection system is an angiographic injection system used in interventional cardiology, radiology, and vascular surgical procedures. The ACIST injection… |
| Product code | DXT |
| Recalling firm | Acist Medical Systems |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2011 |
| 510(k) numbers | K010390, K991103 |
| 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