Reported Jul 11, 2018 · Ongoing

GE Healthcare CARESCAPE Monitor B650

GE Healthcare Finland Oy

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: GE Healthcare Finland Oy · Kuortaneenkatu 2 · Helsinki · N/A

Is this the product you have?

  • GE Healthcare CARESCAPE Monitor B650
Lot codes and dates
  • Serial Numbers

    2,172 of 2,172 codes

    • SEW13497373HA
    • SEW13497374HA
    • SEW13497375HA
    • SEW13497376HA
    • SEW13508068HA
    • SEW12494591HA
    • SEW14280294HA
    • SEW14280298HA
    • SEW14289769HA
    • SEW14289777HA
    • SK416341018HA
    • SK416341019HA
    • SK416341026HA
    • SEW12494422HA
    • SEW12494425HA
    • SEW12494435HA
    • SEW12494584HA
    • SEW12494585HA
    • SEW12494592HA
    • SEW12494593HA
    • SEW12494596HA
    • SEW12494598HA
    • SEW12494619HA
    • SEW12494621HA
    • SEW12494622HA
    • SEW12494625HA
    • SEW12494626HA
    • SEW12504918HA
    • SEW12504923HA
    • SEW12504940HA
    • SEW12504942HA
    • SEW12504944HA
    • SEW12504954HA
    • SEW14278996HA
    • SEW14279002HA
    • SEW14279003HA
    • SEW14279005HA
    • SK416061047HA
    • SK416061048HA
    • SK416061088HA
    • SK416081102HA
    • SK416461063HA
    • SK416461092HA
    • SEW13109786HA
    • SEW12059577HA
    • SEW12059583HA
    • SEW12059587HA
    • SEW12059589HA
    • SEW12059592HA
    • SEW12059593HA
    • SEW12059594HA
    • SEW12059596HA
    • SEW12059597HA
    • SEW12059598HA
    • SEW12059599HA
    • SEW12059601HA
    • SEW13275956HA
    • SEW13276028HA
    • SEW13276029HA
    • SEW13275967HA
    SK
Amount recalled
69231 units

Why it was recalled

When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not be completed until the network issue has been corrected.

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, 4:46 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.