Device recall
Z-0833-2015: Centricity Enterprise Archive is a software product for receiving, archiving and…
FDA device recall · Class II · Ge Healthcare It
Key facts
| Recall number (Z-number) | Z-0833-2015 |
|---|---|
| Recall event | 64760 |
| Product | Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems… |
| Product code | LMB |
| Recalling firm | Ge Healthcare It |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2016 |
| FEI number | 3004526608 |
At a glance
- None 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