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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description 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.
Recall Number Z-1646-2014
Classification Class II
Code Info Model XIRIS 8.1 version XIRIS 8.1.50.0
Product Distributed Qty 5 units
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

Event Detail

Event Id 68262
Product Type Devices
Status Ongoing
Recalling Firm Philips Healthcare Informatics, Inc.
City Foster City
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
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