Device recall
Z-1056-2023: GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8…
FDA device recall · Class I · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Key facts
| Recall number (Z-number) | Z-1056-2023 |
|---|---|
| Recall event | 91456 |
| Product | GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System |
| Product code | KPS |
| Recalling firm | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K121019 |
| 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