Device recall
Z-1027-2016: NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes…
FDA device recall · Class II · NeoCoil, LLC
Key facts
| Recall number (Z-number) | Z-1027-2016 |
|---|---|
| Recall event | 72976 |
| Product | NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M… |
| Product code | MOS |
| Recalling firm | NeoCoil, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 12, 2016 |
| 510(k) numbers | K103342 |
| FEI number | 3006369484 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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