Device recall
Z-0034-2014: Centricity Cardio Imaging 5.0 is a software only Picture Archiving and…
FDA device recall · Class II · GE Healthcare It
Key facts
| Recall number (Z-number) | Z-0034-2014 |
|---|---|
| Recall event | 64787 |
| Product | Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data… |
| Product code | LLZ |
| Recalling firm | GE Healthcare It |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2016 |
| 510(k) numbers | K112570 |
| FEI number | 3004526608 |
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