Reported Sep 2, 2020 · Terminated

CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled,…

GE Healthcare, 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: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615

Is this the product you have?

  • CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
Lot codes and dates
  • CARESCAPE R8601506-8600-000
  • Spare partsCARESCAPE
  • R860
    • 1505-3215-000
    • 2071409-S
    • 2071410-001
  • Engstrom

    2,007 of 2,007 codes

    • M1115997-S
    • M1081816-S Identifier # CBRZ03152
    • CBRZ03159
    • CBRZ03171
    • CBRZ03173
    • CBRZ03174
    • CBRZ03175
    • CBRZ03176
    • CBRZ03177
    • CBRZ03180
    • CBRZ03182
    • CBRZ03867
    • CBRZ03869
    • CBRZ03870
    • CBRZ03873
    • CBRZ03856
    • CBRZ03259
    • CBRZ03261
    • CBRZ03263
    • CBRZ03264
    • CBRZ03265
    • CBRZ03267
    • CBRZ03274
    • CBRZ03275
    • CBRZ03278
    • CBRZ03281
    • CBRZ03928
    • CBRZ03946
    • CBRZ03989
    • CBRZ03990
    • CBRZ03994
    • CBRZ03845
    • CBRZ03857
    • CBRZ03858
    • CBRZ03861
    • CBRZ03868
    • CBRZ03872
    • CBRZ03879
    • CBRZ03880
    • CBRZ03881
    • CBRZ03883
    • CBRZ03889
    • CBRZ03890
    • CBRZ03891
    • CBRZ03484
    • CBRZ03485
    • CBRZ03487
    • CBRZ03488
    • CBRZ03490
    • CBRZ03502
    • CBRZ03793
    • CBRZ03842
    • CBRZ03843
    • CBRZ03849
    • CBRZ03850
    • CBRZ03851
    • CBRZ03853
    • CBRZ03864
    • CBRZ03865
    • CBRZ03866
Amount recalled
2277 units

Why it was recalled

The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.

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

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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 Sep 23, 2024 · Data as of Sep 19, 5:26 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.