Device recall
Z-2040-2024: MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB…
FDA device recall · Class II · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Key facts
| Recall number (Z-number) | Z-2040-2024 |
|---|---|
| Recall event | 94557 |
| Product | MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system). |
| Product code | KPS |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K212004 |
| FEI number | 3004571294 |
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