GE Healthcare, CARESCAPE Monitor B650
Medical device recall Z-2256-2013. Published in FDA’s Enforcement Report on Sep 25, 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 Sep 25, 2013. Copied from openFDA on Oct 24, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 40 states named
- 9466 (3261 US, 6205 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 a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
FDA, Device recall enforcement reports. Released Oct 23, 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. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) 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.
9466 (3261 US, 6205 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Codes to check against yours
Parent SN SEW10233202HA SEW10233203HA SEW10233204HA SEW10233206HA SEW10233209HA SEW10233210HA SEW10243447HA SEW10243449HA SEW10243450HA SEW10243458HA SEW10243476HA SEW10243477HA SEW10243478HA SEW10243479HA SEW10243481HA SEW10243482HA…
Every code shown here, 1,998 characters
Parent SN SEW10233202HA SEW10233203HA SEW10233204HA SEW10233206HA SEW10233209HA SEW10233210HA SEW10243447HA SEW10243449HA SEW10243450HA SEW10243458HA SEW10243476HA SEW10243477HA SEW10243478HA SEW10243479HA SEW10243481HA SEW10243482HA SEW10243484HA SEW10243486HA SEW10243487HA SEW10243489HA SEW10243490HA SEW10243491HA SEW10243492HA SEW10243496HA SEW10243498HA SEW10243499HA SEW10243500HA SEW10243503HA SEW10243504HA SEW10354687HA SEW10354688HA SEW10354694HA SEW10354695HA SEW10354696HA SEW10354697HA SEW10354701HA SEW10354704HA SEW10354706HA SEW10354707HA SEW10354708HA SEW10354709HA SEW10354712HA SEW10354713HA SEW10354717HA SEW10354722HA SEW10354724HA SEW10354728HA SEW10354730HA SEW10354736HA SEW10354738HA SEW10354740HA SEW10354741HA SEW10354746HA SEW10354749HA SEW10354751HA SEW10354752HA SEW10354754HA SEW10354756HA SEW10354757HA SEW10354758HA SEW10354759HA SEW10354760HA SEW10354761HA SEW10354762HA SEW10354763HA SEW10354764HA SEW10354767HA SEW10354768HA SEW10354773HA SEW10354774HA SEW10354775HA SEW10354776HA SEW10354777HA SEW10354778HA SEW10354780HA SEW10354781HA SEW10354783HA SEW10354784HA SEW10385221HA SEW10385223HA SEW10385225HA SEW10385226HA SEW10385227HA SEW10385228HA SEW10385229HA SEW10385230HA SEW10385231HA SEW10385232HA SEW10385234HA SEW10385236HA SEW10385256HA SEW10393672HA SEW10393675HA SEW10393682HA SEW10393747HA SEW10405542HA SEW10405618HA SEW10405648HA SEW10405669HA SEW10405670HA SEW10405673HA SEW10405696HA SEW10446451HA SEW10446466HA SEW10456855HA SEW10467083HA SEW10467133HA SEW10467151HA SEW10467216HA SEW10467289HA SEW10517983HA SEW10528081HA SEW10528111HA SEW11018531HA SEW11018538HA SEW11018545HA SEW11018644HA SEW11018645HA SEW11018646HA SEW11018647HA SEW11018650HA SEW11018651HA SEW11018652HA SEW11018653HA SEW11018702HA SEW11018721HA SEW11018725HA SEW11018729HA SEW11018730HA SEW11018731HA SEW11018732HA SEW11038851HA SEW11038910HA SEW11038918HA SEW11059070HA SEW11059082HA SEW11059083HA SEW11059084HA SEW11059128HA SEW11059129HA SEW11059130HA SEW11059131HA…
FDA’s list runs to 45,650 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, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV,NH, NH, NM, NY, NC, OH, OK OR, PA, PR, SC, TN, TX, VA, WA, WV, WI and WY., and the countries of : ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, COLOMBIA, COSTA RICA. CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, HONG KONG, HUNGARIA, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MALAYSIA, MOROCCO, NETHERLAND, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VENEZUELA.
The states and territories these words name
40 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
- 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 12, 2012.
- FDA classified it on Sep 19, 2013.
- FDA’s Enforcement Report published it on Sep 25, 2013.
- FDA terminated it on Apr 21, 2014.
FDA, Device recall enforcement reports. Released Oct 23, 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 23, 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 45,650 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 23, 2026 and checked Oct 23, 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 24, 2026.