Reported Jun 18, 2014 · Terminated

IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350,…

Philips Medical Systems, Inc.

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 Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Lot codes and dates
  • Serial numbers within the following
  • ranges that have the MX40 interfaces00700001 - US01443745 and US014Z1301 - US014Z1431
Amount recalled
42,600

Where it was sold

  • Nationwide

Why it was recalled

IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated May 16, 2018 · Data as of Sep 19, 6:14 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.