Company: Philips Healthcare Informatics, Inc.
Date of Enforcement Report 5/28/2014
Class lI:
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.
Recall Number Z-1646-2014
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc.Foster City, CA on 5/5/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
