The Recall Desk
HighFDA (Devices)·Z-1646-2014·Announced 2014-05-28

Philips XIRIS 8.1.50.0 Recall Due to Patient Data Synchronization Error

Philips Healthcare Informatics is recalling 5 units of XIRIS 8.1.50.0 due to a synchronization error that may display incorrect patient information.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential patient safety risks without confirmed harm.

Plain-English summary

Philips Healthcare Informatics, Inc. is recalling 5 units of the Philips XIRIS 8.1.50.0 radiology information system (RIS). The recall involves the XRE dictation editor system included in the software. The affected units were distributed worldwide, including in the United States (Florida and Texas), Canada, and South Africa.

The recall is due to a synchronization error that can occur when using XIRIS Rio version 8.1.50.0 in conjunction with iSite PACS. If this error is not noticed, information for the incorrect patient may be displayed. This poses a risk of patient safety issues due to the potential for misidentification of patient data.

Healthcare facilities using this specific version of the software should contact Philips Healthcare Informatics for further instructions on how to resolve the synchronization issue.

The recalled product

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
Manufacturer
Philips Healthcare Informatics, Inc.
Category
Medical Device — Radiology Information System
Hazard
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model XIRIS 8.1 version XIRIS 8.1.50.0

Distribution

Distributed in 2 states:

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