FDAFDA · Food and drugs·Recall number 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 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.
Published May 28, 2014 · Recall initiated: May 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Healthcare Informatics, Inc.
- Distributor
- Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
- Lot
- Model XIRIS 8.1 version XIRIS 8.1.50.0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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