GE Healthcare, CARESCAPE Monitor B650
Medical device recall Z-2114-2014. Published in FDA’s Enforcement Report on Jul 30, 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 Jul 30, 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
- 21,799 (7,635 units US, 14,164 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?
Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
21,799 (7,635 units US, 14,164 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 SEW10233202HA M1176021-052037 SEW10233203HA M1176021 SEW10233204HA M1176021-052037 SEW10233206HA M1176021-052037 SEW10233209HA M1176021-052037 SEW10233210HA M1176021-052037 SEW10243447HA M1176021-052037…
Every code shown here, 1,998 characters
Mfg Lot or Serial # System ID SEW10233202HA M1176021-052037 SEW10233203HA M1176021 SEW10233204HA M1176021-052037 SEW10233206HA M1176021-052037 SEW10233209HA M1176021-052037 SEW10233210HA M1176021-052037 SEW10243447HA M1176021-052037 SEW10243449HA M1176021-052037 SEW10243450HA M1176021-052037 SEW10243458HA M1176021-052037 SEW10243476HA M1176021-052037 SEW10243477HA M1176021-052037 SEW10243478HA M1176021-052037 SEW10243479HA M1176021-052037 SEW10243481HA M1176021-052037 SEW10243482HA M1176021-052037 SEW10243484HA M1176021-052037 SEW10243486HA M1176021-052037 SEW10243487HA M1176021-052037 SEW10243489HA M1176021-052037 SEW10243490HA M1176021-052037 SEW10243491HA M1176021-052037 SEW10243492HA M1176021-052037 SEW10243496HA M1176021-052037 SEW10243499HA M1176021-052037 SEW10243500HA M1176021-052037 SEW10243503HA M1176021-052037 SEW10243504HA M1176021-052037 SEW10354687HA M1176021 SEW10354688HA M1176021 SEW10354694HA M1176021-052037 SEW10354695HA M1176021-052037 SEW10354696HA M1176021-052037 SEW10354697HA M1176021-052037 SEW10354701HA M1176021-052037 SEW10354704HA M1176021 SEW10354706HA M1176021-052037 SEW10354707HA M1176021-052037 SEW10354708HA M1176021-052037 SEW10354709HA M1176021-052037 SEW10354712HA M1176021-052037 SEW10354713HA M1176021-052037 SEW10354717HA M1176021 SEW10354722HA M1176021-052037 SEW10354724HA M1176021-052037 SEW10354728HA M1176021-052037 SEW10354730HA M1176021-052037 SEW10354736HA M1176021-052037 SEW10354738HA M1176021 SEW10354740HA M1176021-052037 SEW10354741HA M1176021-052037 SEW10354746HA M1176021-052037 SEW10354749HA M1176021-052037 SEW10354751HA M1176021-052037 SEW10354752HA M1176021-052037 SEW10354754HA M1176021-052037 SEW10354756HA M1176021-052037 SEW10354757HA M1176021-052037 SEW10354758HA M1176021-052037 SEW10354759HA M1176021-052037 SEW10354760HA M1176021-052037 SEW10354761HA M1176021-052037 SEW10354762HA M1176021-052037 SEW10354763HA M1176021-052037 SEW10354764HA M1176021-052037 SEW10354767HA M1176021-052037 SEW10354768HA M1176021-052037…
FDA’s list runs to 674,687 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 including Puerto Rico, ZAMBIA, YEMEN, VIETNAM, VENEZUELA, URUGUAY, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, UNITED REPUBLIC OF TANZANIA, TAJIKISTAN, TAIWAN, SYRIA, SWITZERLAND, SWEDEN, SRILANKA, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN F¿D¿RATION, ROMANIA, QATAR, PORTUGAL, POLAND, PHILIPPINES, PERU, PARAGUAY, PANAMA, PAKISTAN, OMAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLAND, NAMIBIA, MYANMAR, MOROCCO, MEXICO, MAURITIUS, MALAYSIA, LITHUANIA, LIBYAN ARAB JAMAHIRIYA, LEBANON, LATVIA, KUWAIT, REPUBLIC OF KOREA, KAZAKHSTAN, JORDAN, Italy, JAPAN, JAMAICA, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, HONG KONG, HONDURAS, GUATEMALA, GREECE, GERMANY, GEORGIA, FRANCE, FINLAND, ESTONIA, EL SALVADOR, Egypt, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRUNEI, BRAZIL, BOLIVIA, BERMUDA, BELGIUM, BANGLADESH, BAHRAIN, BAHAMAS, AZERBAIJAN, AUSTRIA, AUSTRALIA, ARGENTINA.
The states and territories these words name
- Georgia
- Puerto Rico
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 7, 2014.
- FDA classified it on Jul 24, 2014.
- FDA’s Enforcement Report published it on Jul 30, 2014.
- FDA terminated it on Sep 7, 2016.
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 674,687 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.