Z-0776-2018Class II

Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue...

Name: Z-0776-2018 Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue...
Creator: Philips Electronics North America Corporation
Published: 2018-01-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-01-03 / Terminated / root cause: software

FDA source

Philips Electronics North America Corporation began a recall of Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade... on 2018-01-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0776-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-03
Posted: 2018-02-28
Terminated: 2019-11-14
Recalling firm: Philips North America LLC
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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0776-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0776-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-28

Product code MHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)