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U.S. Department of Health and Human Services

Class 2 Device Recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50

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  Class 2 Device Recall Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 see related information
Date Initiated by Firm May 05, 2014
Date Posted May 21, 2014
Recall Status1 Terminated 3 on April 28, 2015
Recall Number Z-1646-2014
Recall Event ID 68262
Product Classification Medical device data system - Product Code OUG
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.
Code Information Model XIRIS 8.1 version XIRIS 8.1.50.0
Recalling Firm/
Manufacturer		 Philips Healthcare Informatics, Inc.
4100 E 3rd Ave Ste 101
Foster City CA 94404-4819
For Additional Information Contact Deana Wiseman
650-293-2659
Manufacturer 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
FDA Determined
Cause 2		 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 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
Quantity in Commerce 5 units
Distribution Worldwide Distribution - US including the states of FL and TX and the countries Canada and South Africa.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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