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

FDA device recall Z-1646-2014 · posted 2014-05-21 · Terminated

Recall details

Recalling firm

Philips Healthcare Informatics, Inc.

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

Action taken

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 OneEMSProd@philips.com

Root cause

Software design

Status

Terminated

Product code

OUG

Quantity affected

5 units

Distribution

Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.

Date initiated

2014-05-05

Date posted

2014-05-21

Date terminated

2015-04-28

Location

Foster City, CA