Reported May 28, 2014 · Terminated

Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system…

Philips Healthcare Informatics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Healthcare Informatics, Inc. · 4100 E 3rd Ave Ste 101 · Foster City, CA · 94404-4819

Is this the product you have?

  • 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.
Lot codes and dates
  • Model XIRIS 8.1 version XIRIS 8.1.50.0
Amount recalled
5 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 28, 2015 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.