Recall Z-1646-2014 ยท OUG Medical Device Data System
Philips Healthcare Informatics, Inc.
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.
| Date | May 21, 2014 (initiated May 5, 2014) |
| Status | Terminated |
| 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 |
| 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 de |
| Quantity | 5 units |
| Distribution | Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.