Z-1646-2014 Class II Terminated

Recalled by Philips Healthcare Informatics, Inc. — Foster City, CA

Recall Details

Product Type
Devices
Report Date
May 28, 2014
Initiation Date
May 5, 2014
Termination Date
April 28, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

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.

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

Distribution Pattern

Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.

Code Information

Model XIRIS 8.1 version XIRIS 8.1.50.0