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
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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.
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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 |
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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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510(K) Database | 510(K)s with Product Code = MHX
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