Z-1646-2014 Class II Terminated
FDA device recall Z-1646-2014 was initiated by Philips Healthcare Informatics, Inc. on May 5, 2014 and is designated Class II. 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 The recall status is terminated (terminated April 28, 2015). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 28, 2014
- Initiation Date
- May 5, 2014
- Termination Date
- April 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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
Distribution Pattern
Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
Code Information
Model XIRIS 8.1 version XIRIS 8.1.50.0