Device recall
Z-0111-2019: GE Healthcare MRI Systems, Software Version 12.x, sold under the following…
FDA device recall · Class II · GE Medical Systems, LLC
Key facts
| Recall number (Z-number) | Z-0111-2019 |
|---|---|
| Recall event | 80323 |
| Product | GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5 HISPEED HD 4-CH 200-AP… |
| Product code | LNH |
| Recalling firm | GE Medical Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2020 |
| 510(k) numbers | K012200, K013636, K030874, K040444, K041476, K052293 |
| FEI number | 2183553 |
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