CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient…
Medical device recall Z-1567-2013. Published in FDA’s Enforcement Report on Jul 3, 2013.
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 Jul 3, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 44 states named
- 12,779 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 become aware of 4 potential issues associated with the CARESCAPE Monitor B850. These issues include CARESCAPE Monitor B850 uDOM failure, CARESCAPE Monitor B850 unstable USB communication, CARESCAPE Monitor B850 remote printing issue with currently printing PRN 50 recorder and CARESCAPE Monitor B850 reboots due to an X server freeze.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of Hemodynamics, Airway Gases (Fi/Et CO2, O2, N2) and Anesthetic Agent), Spirometry, Gas Exchange (O2 Consumption (VO2), CO2 production (VCO2), energy expenditure (EE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. It is a stand-alone monitor or interfaced to other devices. is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI.
12,779, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # SED11107648GA SED11107652GA SED11117927GA SED11117959GA SED11168563GA SED10293123GA SED10293124GA SED10353742GA SED10353743GA SED10132473GA SED10303335GA SED10333640GA SED11178619GA SED10142532GA SED10485114GA…
Every code shown here, 1,994 characters
Mfg Lot or Serial # SED11107648GA SED11107652GA SED11117927GA SED11117959GA SED11168563GA SED10293123GA SED10293124GA SED10353742GA SED10353743GA SED10132473GA SED10303335GA SED10333640GA SED11178619GA SED10142532GA SED10485114GA SED09340621GA SED09340629GA SED09340640GA SED09340654GA SED09340655GA SED09471473GA SED10021715GA SED10021720GA SED10041824GA SED10112150GA SED10112155GA SED10112156GA SED10112165GA SED10112173GA SED10112199GA SED10122287GA SED10122288GA SED10122291GA SED10122297GA SED10122314GA SED10122331GA SED10122332GA SED10122334GA SED10122335GA SED09090248GP SED09130299GP SED09130301GP SED09130304GP SED09130308GP SED09130309GP SED09130310GP SED09130313GP SED09491635GA SED10505510GA SED11067055GA SED11077158GA SED11077165GA SED11087325GA SED11087333GA SED11087361GA SED11097434GA SED11097448GA SED11097449GA SED11097455GA SED11097498GA SED11097532GA SED11097536GA SED11097543GA SED11097546GA SED11097547GA SED11097548GA SED11097549GA SED11097550GA SED11097583GA SED11097584GA SED11097586GA SED11097587GA SED11097588GA SED11097605GA SED11097608GA SED11107621GA SED11107643GA SED11107664GA SED11107720GA SED11107747GA SED11107751GA SED11107767GA SED11107770GA SED11107780GA SED11117928GA SED11117932GA SED11117942GA SED11117943GA SED11128168GA SED11138226GA SED11138229GA SED11138241GA SED11138280GA SED11138286GA SED11138291GA SED11138292GA SED11138293GA SED11148304GA SED11148312GA SED11148328GA SED11148330GA SED11148360GA SED11158467GA SED11158469GA SED11158487GA SED11158546GA SED11178637GA SED11178638GA SED11178763GA SED11209189GA SED11209203GA SED11229449GA SED11229557GA SED11229558GA SED11229562GA SED11300276GA SED11300278GA SED11300293GA SED11310421GA SED11330608GA SED11330642GA SED11330644GA SED11340655GA SED11441024GA SED11441025GA SED11451048GA SED12011208GA SED12011227GA SED12011235GA SED12021259GA SED12051638GA SED12051640GA SED12051649GA SED12051653GA SED12051656GA SED12051667GA SED12051669GA SED12051671GA SED12051673GA SED12051674GA SED12051679GA…
FDA’s list runs to 189,422 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 - USA Nationwide including the states of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS, KY, IA, ME, MD,MA, MI, MN, MS, MO, MT, NE,NV,NH, NJ, NM, NY, NC, OR, OK OH, PA, PR, SC, TN, TX, UT, VA, WA, WY, WI, WY, and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK,, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLAND, NEW ZEALAND, NORWAY, PANAMA, PERU, POLAND, PORTUGAL, QATAR, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
The states and territories these words name
44 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- Wyoming
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 Jul 20, 2012.
- FDA classified it on Jun 21, 2013.
- FDA’s Enforcement Report published it on Jul 3, 2013.
- FDA terminated it on Jun 30, 2014.
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 189,422 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.