Home / Recalls / Philips Electronics North America Corporation / Z-0776-2018

Z-0776-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
January 3, 2018
Termination Date
November 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

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  • Z-0592-2019 Class II — IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Pro (October 10, 2018)
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  • Z-3228-2018 Class II — AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3232-2018 Class II — Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and n (July 16, 2018)
  • Z-3237-2018 Class II — Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and ne (July 16, 2018)
  • Z-3213-2018 Class II — INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3236-2018 Class II — Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascul (July 16, 2018)
  • Z-3238-2018 Class II — Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular a (July 16, 2018)
  • Z-3239-2018 Class II — Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and (July 16, 2018)