FDA Device recall Z-1646-2014
Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer s…
- FDA Device
- Class II
- terminated
- Published 2014-05-28
On 2014-05-28 the FDA classified a Class II recall of Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer s… by Philips Healthcare Informatics, citing when using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1646-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-05 |
| Published | 2014-05-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare Informatics |
| Distribution | FL, TX |
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 workflow and reporting management.
Reason
When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed
Identifiers
| code_info | Model XIRIS 8.1 version XIRIS 8.1.50.0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1646-2014%22
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