Z-0776-2018 Class II Terminated
FDA device recall Z-0776-2018 was initiated by Philips Electronics North America Corporation on Jan 3, 2018 and is designated Class II. 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… The recall status is terminated (terminated Nov 14, 2019). Affected quantity: 20357.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 7, 2018
- Initiation Date
- Jan 3, 2018
- Termination Date
- Nov 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20357
Product Description
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
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.
Distribution Pattern
Domestic and Foreign
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0776-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026