Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips XRE Recalled by Philips Healthcare Informatics, Inc. Due to When using XIRIS Rio version (8.1.50.0) in conjuncture...

Date: May 5, 2014
Company: Philips Healthcare Informatics, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare Informatics, Inc. directly.

Affected Products

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.

Quantity: 5 units

Why Was This 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

Where Was This Sold?

This product was distributed to 2 states: FL, TX

Affected (2 states)Not affected

About Philips Healthcare Informatics, Inc.

Philips Healthcare Informatics, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report