Device recall
Z-0189-2015: Brivo NM615, is an all-purpose, single detector integrated nuclear imaging…
FDA device recall · Class II · GE Healthcare, LLC
Key facts
| Recall number (Z-number) | Z-0189-2015 |
|---|---|
| Recall event | 69570 |
| Product | Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the… |
| Product code | KPS |
| Recalling firm | GE Healthcare, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 27, 2015 |
| 510(k) numbers | K022960, K052434, K991841 |
| FEI number | 2126677 |
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