Home / Recalls / Philips Electronics North America Corporation / Z-0292-2018

Z-0292-2018 Class II Ongoing

Recalled by Philips Electronics North America Corporation — Andover, MA

Recall Details

Product Type
Devices
Report Date
January 3, 2018
Initiation Date
August 23, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7071

Product Description

IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.

Reason for Recall

Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors

Distribution Pattern

Worldwide Distribution and US Nationwide

Code Information

Model #: M300IA/AL, M3002A, M8102A, M8105A with ECO FW revision E.0 1.22 and 12-lead option C#12 Lots #s included on Consignee list Catalog #: 862442 (M3001A), 866462 (M3001AL), 865039 (M3002A), 865040 (M8102A), 865024 (M8105A)

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  • 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-3215-2018 Class II — INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular i (July 16, 2018)
  • Z-3213-2018 Class II — INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3238-2018 Class II — Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular a (July 16, 2018)