Device recall
Z-1904-2010: Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator…
FDA device recall · Class II · Mallinckrodt Inc
Key facts
| Recall number (Z-number) | Z-1904-2010 |
|---|---|
| Recall event | 55953 |
| Product | Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table. |
| Product code | IZO |
| Recalling firm | Mallinckrodt Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 25, 2012 |
| 510(k) numbers | K920742, K943581 |
| FEI number | 1518293 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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