GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2
Medical device recall Z-0096-2019. Published in FDA’s Enforcement Report on Oct 17, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 17, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 47,937 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
When multiple CARESCAPEMonitor B450 or B850 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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 is indicated for monitoring of: -hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation). -Respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange) and -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission. The CARESCAPE Monitor B850 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.
47,937 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: No UDI: SKA14365373GA SKA16085338SA SKA16085415SA SED11178711GA SED11178722GA SED11178730GA SED11178731GA SED12384211GA SKA16065074SA SKA16065096SA SKA16105698SA SKA16105700SA SED11148380GR SED11168558GR SED11229587GR…
Every code shown here, 1,998 characters
Serial Numbers: No UDI: SKA14365373GA SKA16085338SA SKA16085415SA SED11178711GA SED11178722GA SED11178730GA SED11178731GA SED12384211GA SKA16065074SA SKA16065096SA SKA16105698SA SKA16105700SA SED11148380GR SED11168558GR SED11229587GR SED12183123GA SED12183126GA SED12273483GA SED12353647GA SED12353648GA SED12363714GA SED12363728GA SED12373928GA SED09320537GA SED11300215GR SED11300224GR SED11300285GR SED11300317GR SED11300318GR SED11420905GR SED11420906GR SED11420913GR SED11420919GR SED11420923GR SED11420926GR SED11420927GR SED11420928GR SED11420929GR SED11420930GR SED11420931GR SED11430946GR SED11430947GR SED11430949GR SED11430967GR SED11430970GR SED11430971GR SED12152834GR SED12152838GR SED12203208GR SED12203211GR SED12203212GR SED12203213GR SED12203254GR SED12203257GR SED12203258GR SED12203259GR SED12253445GR SED12263455GR SKA14365468GA SED11097478GR SED11158484GR SED11229574GR SED11229586GR SED11229600GR SED11290119GR SED11290121GR SED11290179GR SED11300185GR SED11300206GR SED11300237GR SED11400754GR SED11400808GR SED11400820GR SED11400822GR SED11410865GR SED12011230GR SED12061751GR SED12061776GR SED12092232GR SED12203277GR SED12263465GR SED12374154GR SKA14042213GA SKA14042214GA SKA14042217GA SKA14042221GA SED10384067GA SED11117907GA SED11117984GA SED14011320GA SED12384438GA SED12384442GA SED12384447GA SED12384459GA SED12384462GA SED12384465GA SED12384467GA SED12384473GA SED12384476GA SED12384477GA SED12384480GA SED12384482GA SKA15150527GA SKA15160548GA SED11087355GA SED11087409GA SED12092223GA SED12092227GA SED12485925GA SED12485926GA SKA15109642GA SKA15109644GA SKA15109647GA SED09370825GA SKA15361685SA SKA15361687SA SED12173064GR SED10132516GA SED10142524GA SED10142526GA SED10142528GA SED10252889GA SED10252891GA SED10252895GA SED10252920GA SED10252921GA SED10252922GA SED10252926GA SED11320473GA SED11320475GA SED11461073GA SKA16075189SA SKA16075222SA SKA16075223SA SED11178786GA SED11178791GA SED11178795GA SED11178801GA SKA15412512SA SKA14062442GR SKA14143028GR…
FDA’s list runs to 1,088,089 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution-US Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 4, 2018.
- FDA classified it on Oct 10, 2018.
- FDA’s Enforcement Report published it on Oct 17, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare Finland Oy, of Helsinki, Finland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 1,088,089 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.