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Recall Observatory FDA recall evidence

Device 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.

Z-1646-2014

May 05, 2014

Class II

Product summary

Firm
Philips Healthcare Informatics, Inc.
Event
Event 68262
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1646-2014

Official wording

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

Code information: Model XIRIS 8.1 version XIRIS 8.1.50.0

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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