GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450
Medical device recall Z-0095-2019. 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
- 59,000 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 B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B450 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), and spirometry) -neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
59,000 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: SJA15150092HA SJA15150100HA SJA15150124HA SJA15150125HA SJA15150126HA SJA15150127HA SJA15150128HA SJA15150139HA SJA15170033HA SJA15170079HA SJA15170081HA SJA15170085HA SJA15170086HA SJA15170087HA SJA15170088HA…
Every code shown here, 1,998 characters
Serial numbers: No UDI: SJA15150092HA SJA15150100HA SJA15150124HA SJA15150125HA SJA15150126HA SJA15150127HA SJA15150128HA SJA15150139HA SJA15170033HA SJA15170079HA SJA15170081HA SJA15170085HA SJA15170086HA SJA15170087HA SJA15170088HA SJA15170089HA SJA15170090HA SJA15170091HA SNE16060190HA SNE16110218HA SJA14127613HA SJA14127614HA SJA15262026HA SJA15262173HA SJA15272036HA SJA15282008HA SJA15282009HA SJA15282010HA SJA15282014HA SJA15282015HA SJA15282016HA SJA15282017HA SJA15282019HA SJA15282022HA SJA15282024HA SJA15282043HA SJA15282044HA SJA15282048HA SJA15282051HA SJA15282054HA SJA15282055HA SJA15282059HA SJA15282060HA SJA15282063HA SJA15282065HA SJA15282118HA SJA15282122HA SJA15282125HA SJA15282128HA SJA15282129HA SJA15282131HA SJA15282134HA SJA15282135HA SJA15282141HA SJA15282149HA SJA15382048HA SJA14437335HA SJA14437337HA SJA14127619HA SJA14127621HA SJA14127622HA SJA14127623HA SJA14127624HA SJA14127626HA SJA14392398HA SJA14392402HA SJA14192489HR SJA14302513HR SJA15401023HR SJA15170060HA SJA15170127HA SJA15170128HA SJA15170129HA SJA15170130HA SJA15170137HA SJA15292063HA SJA14473730HA SNE15480016HA SNE15480017HA SNE15480019HA SNE15511032HA SJA15342151HA SJA15342152HA SJA15252097HA SJA15252142HA SJA15252143HA SJA15252144HA SJA15252149HA SJA15252150HA SJA15252151HA SJA15262060HA SJA15262061HA SJA15262062HA SJA15262063HA SJA15262064HA SJA15262068HA SJA15262069HA SJA15262070HA SJA15452019HA SNE15431001HA SNE16010064HA SNE16010070HA SNE16010071HA SNE16010078HA SNE16010079HA SNE16010080HA SJA15262004HA SJA15262005HA SJA14403421HA SJA15101137HA SNE16110060HA SNE16110063HA SNE16110065HA SNE16110066HA SJA15262006HA SNE16080111HA SNE16080112HA SNE16080113HA SNE16080114HA SNE16080115HA SNE16080116HA SNE16080117HA SNE16080118HA SNE16080119HA SNE16080121HA SNE16050129HA SNE16050131HA SNE16120029HR SNE16120040HR SNE15520017HA SNE15520018HA SNE15520019HA SNE15520020HA SNE15520022HA SNE15531045HA SNE15531046HA SNE16010075HA SNE16010076HA SNE16010077HA SNE15520036HA SNE15520079HA…
FDA’s list runs to 2,267,444 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 2,267,444 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.