Philips XRE — Class II medical device recall Z-1646-2014
Terminated recall by Philips Healthcare Informatics, Inc., reported 2014-05-28, distributed in FL, TX. When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and i
| Recall number | Z-1646-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Informatics, Inc., Foster City, CA, United States |
| Recall initiated | 2014-05-05 |
| Classified | 2014-05-21 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2015-04-28 |
| Distributed | FL, TX |
| Countries outside the US | CA, ZA |
| Quantity | 5 units |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1646-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.