FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: 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
- Recall number
- Z-0776-2018
- Recalling firm
- Philips Electronics North America Corporation
- 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
- Status
- Terminated
- Initiated
- 2018-01-03
- Posted
- not on file
- Terminated
- 2019-11-14
- Reason
- 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
- 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
- 20357
- Distribution
- Domestic and Foreign
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K102495","K143057"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28