GE Healthcare, CARESCAPE Monitor B650
Medical device recall Z-0823-2013. Published in FDA’s Enforcement Report on Feb 20, 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 Feb 20, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 32 states named in where it went
- 2813 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 become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, CARESCAPE Monitor B650. 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.
2813, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SERIAL NUMBER SEW1181782HA SEW11243524HA SEW11223123HA SEW11223122HA SEW11223121HA SEW11223108HA SEW11223107HA SEW11223106HA SEW11223092HA SEW11223086HA SEW11223085HA SEW11223082HA SEW11223070HA SEW11223022HA SEW11223019HA SEW11223011HA…
Every code shown here, 1,987 characters
SERIAL NUMBER SEW1181782HA SEW11243524HA SEW11223123HA SEW11223122HA SEW11223121HA SEW11223108HA SEW11223107HA SEW11223106HA SEW11223092HA SEW11223086HA SEW11223085HA SEW11223082HA SEW11223070HA SEW11223022HA SEW11223019HA SEW11223011HA SEW11222999HA SEW11222997HA SEW11202780HA SEW11202778HA SEW11202775HA SEW11202753HA SEW11202750HA SEW11202749HA SEW11202746HA SEW11202745HA SEW11202744HA SEW11202742HA SEW11202741HA SEW11202740HA SEW11202739HA SEW11202737HA SEW11202736HA SEW11202717HA SEW11202716HA SEW11202715HA SEW11202713HA SEW11202712HA SEW11202711HA SEW11202709HA SEW11202708HA SEW11202706HA SEW11202705HA SEW11202704HA SEW11202703HA SEW11202702HA SEW11202700HA SEW11202697HA SEW11202690HA SEW11202687HA SEW11202682HA SEW11202401HA SEW11202400HA SEW11202399HA SEW11202398HA SEW11202397HA SEW11202395HA SEW11202394HA SEW11202390HA SEW11202385HA SEW11202384HA SEW11202383HA SEW11202381HA SEW11202379HA SEW11202378HA SEW11202370HA SEW11202369HA SEW11202368HA SEW11202366HA SEW11202363HA SEW11202362HA SEW11202361HA SEW11202360HA SEW11202359HA SEW11202358HA SEW11202357HA SEW11202353HA SEW11202352HA SEW11202351HA SEW11202348HA SEW11202347HA SEW11202341HA SEW11202340HA SEW11202338HA SEW11202337HA SEW11202336HA SEW11202334HA SEW11202332HA SEW11202331HA SEW11202329HA SEW11202328HA SEW11202325HA SEW11202323HA SEW11202322HA SEW11202320HA SEW11202317HA SEW11202313HA SEW11202310HA SEW11202309HA SEW11202307HA SEW11202301HA SEW11202299HA SEW11202298HA SEW11202296HA SEW11202294HA SEW11202291HA SEW11202290HA SEW11202288HA SEW11202287HA SEW11202286HA SEW11202283HA SEW11202220HA SEW11202203HA SEW11202202HA SEW11181949HA SEW11181947HA SEW11181943HA SEW11181941HA SEW11181936HA SEW11181925HA SEW11181923HA SEW11181920HA SEW11181919HA SEW11181908HA SEW11181895HA SEW11181892HA SEW11181886HA SEW11181882HA SEW11181857HA SEW11181848HA SEW11181828HA SEW11181823HA SEW11181813HA SEW11181797HA SEW11181792HA SEW11181790HA SEW11181788HA SEW11181787HA SEW11181785HA SEW11181782HA SEW11181781HA…
FDA’s list runs to 39,395 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 including AL, AZ, AR, CA, CO, CT, FL, GA,IL,IN, IA, KS, KY,LA, MD, MA, MI, M, MO, NE, NE,NJ, NM, NY, NC, OH, OK PA, SC, TN, TX, UT, VA, WI. Internationally to UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, ROMANIA, PORTUGAL, POLAND, PERU, NORWAY, NEW ZEALAND, NETHERLAND, MALAYSIA, LITHUANIA, KUWAIT, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, ICELAND, HONG KONG, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, COLOMBIA, CHILE, CANADA, BELGIUM BAHRAIN, AUSTRIA, AUSTRALIA.
The states and territories these words name
32 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Sep 30, 2011.
- FDA classified it on Feb 14, 2013.
- FDA’s Enforcement Report published it on Feb 20, 2013.
- FDA terminated it on Jan 27, 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 39,395 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
-
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.