GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850
Medical device recall Z-0854-2014. Published in FDA’s Enforcement Report on Feb 5, 2014.
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 Feb 5, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 40,239 (17,182 units US, 23,147 units OUS). 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?
GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilation Alarms:ve Blood Pressure) , ECG, Central Monitor, General, Tram, and Bed to Bed Issues.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. 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 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.
40,239 (17,182 units US, 23,147 units OUS)., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID SED11107669GA 2020913-002 SED12102371GA 2020913-002 SED12455369GA 2020913-002 SED13027435GA 2020913-002 SED13027444GA 2020913-002 SEW11456764HA M1176021-094955 SEW11487296HA M1176021-094955 SEW11487300HA…
Every code shown here, 1,996 characters
Mfg Lot or Serial # System ID SED11107669GA 2020913-002 SED12102371GA 2020913-002 SED12455369GA 2020913-002 SED13027435GA 2020913-002 SED13027444GA 2020913-002 SEW11456764HA M1176021-094955 SEW11487296HA M1176021-094955 SEW11487300HA M1176021-094955 SEW11487304HA M1176021-094955 SEW11487306HA M1176021-094955 SEW11487307HA M1176021-094955 SEW11487308HA M1176021-094955 SEW11487309HA M1176021-094955 SEW11487310HA M1176021-094955 SEW11487312HA M1176021-094955 SEW11487313HA M1176021-094955 SEW11487314HA M1176021-094955 SEW11487315HA M1176021-094955 SEW11487316HA M1176021-094955 SEW11487317HA M1176021-094955 SEW11497510HA M1176021-094955 SEW11497511HA M1176021-094955 SEW11497512HA M1176021-094955 SEW11497513HA M1176021-094955 SEW11497514HA M1176021-094955 SEW11497515HA M1176021-094955 SEW11497517HA M1176021-094955 SEW11497518HA M1176021-094955 SEW11497519HA M1176021-094955 SEW11497532HA M1176021-094955 SEW11497534HA M1176021-094955 SEW11497535HA M1176021-094955 SEW11497536HA M1176021-094955 SEW11497537HA M1176021-094955 SEW11497538HA M1176021-094955 SEW11497539HA M1176021-094955 SEW11497540HA M1176021-094955 SEW11497555HA M1176021-094955 SEW11497556HA M1176021-094955 SEW11497557HA M1176021-094955 SEW11497558HA M1176021-094955 SEW11497560HA M1176021-094955 SEW11497581HA M1176021-094955 SEW11497583HA M1176021-094955 SEW11497584HA M1176021-094955 SEW11497585HA M1176021-094955 SEW12049003HA M1176021-100869 SEW12059331HA M1176021-100713 SEW12316595HA M1176021-120906 SEW12316596HA M1176021-120906 SEW12357363HA M1176021-120906 SEW12357365HA M1176021-120906 SEW12357366HA M1176021-120906 SEW12357368HA M1176021-120906 SEW12357485HA M1176021-120906 SEW12357488HA M1176021-120906 SEW12357489HA M1176021-120906 SEW12357490HA M1176021-120906 SEW13068518HA M1176021-094955 SEW13193084HA M1176021-186679 SEW13193101HA M1176021-186640 SEW13193102HA M1176021-186640 SEW13203400HA M1176021-186640 SEW13244941HA M1176021-187302 SED11168563GA 2020913-002 SED12526653GA 2020913-003 SED12526658GA…
FDA’s list runs to 1,120,922 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.
Nationwide Distribution including DC and PR, except DE, SD, ND, and VT. OUS: Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bolivia,Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic ,Denmark, Ecuador, Egypt, El Salvador, Estonia ,Finland, France, Germany, Greece,Guam, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait,Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, United Republic of Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Uruguay.
The states and territories these words name
- District of Columbia
- Puerto Rico
They leave out Delaware, North Dakota, South Dakota and Vermont.
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Dec 27, 2013.
- FDA classified it on Jan 28, 2014.
- FDA’s Enforcement Report published it on Feb 5, 2014.
- FDA terminated it on Jun 23, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- 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 1,120,922 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.