Device recall
Z-1055-2023: GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch…
FDA device recall · Class I · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Key facts
| Recall number (Z-number) | Z-1055-2023 |
|---|---|
| Recall event | 91456 |
| Product | GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8 inch, c) BRIVO B615 3/8 inch DHP BJG NR, d) B615 with new rotor, e) BRIVO B615 3/8 inch BJG, f) BRIVO B615 3/8 inch DHP BJG NR, g) B615 with new rotor; 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 | K113350 |
| 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