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U.S. Department of Health and Human Services

Class 2 Device Recall Physiological Monitoring, Patient Monitor

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  Class 2 Device Recall Physiological Monitoring, Patient Monitor see related information
Date Initiated by Firm August 23, 2017
Create Date December 27, 2017
Recall Status1 Open3, Classified
Recall Number Z-0292-2018
Recall Event ID 78736
510(K)Number K150975  K150310  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product 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.
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)
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Hauke Schik
800-722-9377
Manufacturer Reason
for Recall		 Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
FDA Determined
Cause 2		 Software design
Action Philips sent an Urgent Medical Device Correction letter to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips will provide software update and is provding interim instructions for the operator. For questions contact your local Philips representative.
Quantity in Commerce 7071
Distribution Worldwide Distribution and US Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MHX and Original Applicant = PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
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