Z-1646-2014Class II

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

Name: Z-1646-2014 Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology...
Creator: Philips Healthcare Informatics, Inc.
Published: 2014-05-05
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-05-05 / Terminated / root cause: software

FDA source

Philips Healthcare Informatics, Inc. began a recall of 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... on 2014-05-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1646-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-05
Posted: 2014-05-21
Terminated: 2015-04-28
Recalling firm: Philips North America LLC
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.
Product code: OUG Medical Device Data System
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
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an Urgent Field Safety Notice dated May 5, 2014. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised of the synchronization problem and request that a copy of this notification be kept with the equipment instructions for use. The document goes on to outline the affected product, the problems and conditions when it can occur. A photo of the label for easy identity the actions to be taken are provided. Philips is informing users of the issue via the notification and will deploy a software correction to all customers when available. Questions may be directed to Philips reps or Care at 1-866-946-4701 or [email protected]
Quantity in commerce: 5 units
Distribution: Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
Product codes and lots: Model XIRIS 8.1 version XIRIS 8.1.50.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1646-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1646-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-28	2014-05-21

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)