Recall Z-1646-2014— Philips Healthcare Informatics, Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare Informatics, Inc., initiated 2014-05-05, terminated 2015-04-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- Philips Healthcare Informatics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-05
- Terminated
- 2015-04-28
- Firm location
- Foster City, CA, United States
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.