Device recall
Z-0937-04: Magnetic Resonance Imaging System Core Software, Software installed in all of…
FDA device recall · Class III · Toshiba American Med Sys Inc
Key facts
| Recall number (Z-number) | Z-0937-04 |
|---|---|
| Recall event | 29020 |
| Product | Magnetic Resonance Imaging System Core Software, Software installed in all of the following: Flexart MRI System, Visart MRI System, Exelart / Exelart P2 / Exelart P3 SPIN & Exelart VANTAGE MRI Systems. |
| Product code | LNH |
| Recalling firm | Toshiba American Med Sys Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 15, 2005 |
| 510(k) numbers | K002531, K933018, K990620, K993803 |
| FEI number | 2020563 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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