Reported May 22, 2019 · Ongoing

SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP,…

Philips North America, LLC

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 North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

Is this the product you have?

  • SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Lot codes and dates
  • Serial NumbersAll
  • Including UDIs(01)00884838028890(21) and (01)00884838087075(21) followed by serial number
Amount recalled
21857

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.

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

Data as of Sep 19, 7:39 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.