Device recall
Z-1214-2012: D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed…
FDA device recall · Class II · Spectrum Dynamics
Key facts
| Recall number (Z-number) | Z-1214-2012 |
|---|---|
| Recall event | 61298 |
| Product | D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM DYNAMICS --- Spectrum Dynamics (Israel) Ltd. 22 Bareket St. North Industrial Park, P.O. Box 3033, Caesarea, 30889 Israel D-SPECT is an emission computed tomography system intended to detect the… |
| Product code | KPS |
| Recalling firm | Spectrum Dynamics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 1, 2015 |
| 510(k) numbers | K072468 |
| FEI number | 3006451238 |
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