Philips Healthcare Informatics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1646-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 5, 2014

Date Posted: May 28, 2014

Recall Number: Z-1646-2014

Event ID: 68262

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

Status: Terminated

Product Quantity: 5 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated