Device recall
Z-1938-2009: Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil)…
FDA device recall · Class II · Quality Electrodynamics Llc
Key facts
| Recall number (Z-number) | Z-1938-2009 |
|---|---|
| Recall event | 51281 |
| Product | Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil Part #Q7000021, Quality Electrodynamics, Mayfield Village, OH 44143. The indications for use are routine MR imaging. |
| Product code | MOS |
| Recalling firm | Quality Electrodynamics Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2012 |
| 510(k) numbers | K083160 |
| FEI number | 3007350713 |
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