Reported Aug 10, 2016 · Terminated

IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever…

Philips Electronics North America Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips Electronics North America Corporation · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • IntelliVue
  • Patient Monitor Product UsageThe monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment
Lot codes and dates
  • Serial Numbers listed for US/VA/DOD Consignees. For OUS serial numbers, plesae refer to customer list.

    2,708 of 2,708 codes

    • DE35122625
    • DE35142133
    • DE35142134
    • DE35115647
    • DE35106078
    • DE35129184
    • DE35129185
    • DE35147659
    • DE35147653
    • DE35119998
    • DE35119999
    • DE35120000
    • DE35120001
    • DE35120021
    • DE35120022
    • DE35120023
    • DE35120024
    • DE35120025
    • DE35120026
    • DE35120027
    • DE35120028
    • DE35120029
    • DE35120030
    • DE35120031
    • DE35120032
    • DE35120034
    • DE35120035
    • DE35120036
    • DE35120037
    • DE35120038
    • DE35120039
    • DE35120040
    • DE35120041
    • DE35120042
    • DE35120043
    • DE35120044
    • DE35120045
    • DE35120046
    • DE35120047
    • DE35120048
    • DE35120052
    • DE35120053
    • DE35120055
    • DE35120056
    • DE35120057
    • DE35120058
    • DE35120059
    • DE35120060
    • DE35120061
    • DE35120062
    • DE35120063
    • DE35120064
    • DE35120065
    • DE35120067
    • DE35120068
    • DE35120069
    • DE35120071
    • DE35120072
    • DE35120079
    • DE35120080
Amount recalled
50,495

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 14, 2020 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.