Device recall
Z-1646-2014: Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50…
FDA device recall · Class II · Philips Healthcare Informatics, Inc.
Key facts
| Recall number (Z-number) | Z-1646-2014 |
|---|---|
| Recall event | 68262 |
| Product | Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and… |
| Product code | OUG |
| Recalling firm | Philips Healthcare Informatics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2015 |
| FEI number | 3002971142 |
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