FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: 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.
- Recall number
- Z-0292-2018
- Recalling firm
- Philips Electronics North America Corporation
- 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.
- Status
- Open, Classified
- Initiated
- 2017-08-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- Distorted ST-Segment when using 12-Lead ECG Monitoring with Philips IntelliVue Patient Monitors
- Root cause
- 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
- 7071
- Distribution
- Worldwide Distribution and US Nationwide
- Lot, serial or model codes
- 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)
- 510(k) numbers
- ["K150310","K150975"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28