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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 Monitorsee related information
Date Initiated by FirmAugust 23, 2017
Create DateDecember 27, 2017
Recall Status1 Open3, Classified
Recall NumberZ-0292-2018
Recall Event ID 78736
510(K)NumberK150310 K150975 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductIntelliVue 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 ContactHauke 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
ActionPhilips 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 Commerce7071
DistributionWorldwide Distribution and US Nationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MHX
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