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U.S. Department of Health and Human Services

Class 2 Device Recall PIIC iX Intellivue iX Information Center Software

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  Class 2 Device Recall PIIC iX Intellivue iX Information Center Software see related information
Date Initiated by Firm January 03, 2018
Create Date February 28, 2018
Recall Status1 Terminated 3 on November 14, 2019
Recall Number Z-0776-2018
Recall Event ID 79132
510(K)Number K102495  K143057  
Product Classification System,network and communication,physiological monitors - Product Code MHX
Product Intellivue iX Information Center Software - All PIIC iX Surveillance stations including:
866023 IntelliVue Info Center iX A.0
866117 PIIC Classic Upgrade
866389 IntelliVue Info Center iX B.0, C.0
867141 IntelliVue Info Center iX B.0
866025 IntelliVue Server IX A.0
866118 Database Server Upgrade A.0
Code Information All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Kristen Phillips
978-659-3000
Manufacturer Reason
for Recall		 Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be corrected, users should avoid intentionally restarting their Surveillance stations in 2018.
FDA Determined
Cause 2		 Software design
Action To avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. You may use the workflows described in attachment Alternative Workflows for PIIC iX to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged. Philips has initiated a correction to address this issue and will provide this software update to customers with affected devices at no charge. Software updates for PIIC iX A.0x and B.0x are expected to be available by January 8th. A Philips Healthcare representative will contact customers with affected devices to arrange for correction of the issue. Contact your local Philips representative if you have a question about any device affected by this issue.
Quantity in Commerce 20357
Distribution Domestic and Foreign
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.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDICAL SYSTEMS
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