GE Healthcare, CARESCAPE Monitor B850, B650 or B450
Medical device recall Z-2085-2014. 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 for where it went
- 41,992 (20,509 US; 21,483 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?
Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
41,992 (20,509 US; 21,483 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CARESCAPE MONITOR B850: Mfg Lot or Serial # System ID PA1793340 2044032-002+940481 PA1841631 2044032-002+956091 PA1841635 2044032-002+956091 PA1841639 2044032-002+956091 PA1962678 2044032-002+950202 SED09130286GP 2042395-001+889146…
Every code shown here, 1,995 characters
CARESCAPE MONITOR B850: Mfg Lot or Serial # System ID PA1793340 2044032-002+940481 PA1841631 2044032-002+956091 PA1841635 2044032-002+956091 PA1841639 2044032-002+956091 PA1962678 2044032-002+950202 SED09130286GP 2042395-001+889146 SED09130290GP 2042395-001+889146 SED09130291GP 2042395-001+889146 SED09130296GP 2042395-001-884783 SED09130298GP 2042395-001+889146 SED09130302GP 2042395-001+889148 SED09130304GP 2042395-001+887796 SED09130307GP 2042395-001-885430 SED09130312GP 2042395-001+889880 SED09180333GP 2042395-001+889148 SED09180334GP 2042395-001+887796 SED09180338GP 2042395-001+889148 SED09180341GP 2042395-001+889880 SED09220344GP 2042395-001+889880 SED09220345GP 2042395-001+889880 SED09220346GP 2042395-001+889880 SED09220347GP 2042395-001+889880 SED09220348GP 2042395-001+889880 SED09220350GP 2042395-001+889880 SED09220355GP 2042395-001+889880 SED09220357GP 2042395-001+889880 SED09220358GP 2042395-001+889880 SED09220365GP 2042395-001+889880 SED09220367GP 2042395-001+889880 SED09220371GP 2042395-001+889880 SED09220372GP 2042395-001+889880 SED09220373GP 2042395-001+889880 SED09220375GP 2042395-001+889880 SED09220377GP 2042395-001+889880 SED09220378GP 2042395-001+889880 SED09220380GP 2042395-001+889880 SED09220381GP 2042395-001+889880 SED09220382GP 2042395-001+889880 SED09220383GP 2042395-001+889880 SED09230384GP 2042395-001+889880 SED09230385GP 2042395-001+889880 SED09230386GP 2042395-001+889880 SED09230388GP 2042395-001+889880 SED09230390GP 2042395-001+889880 SED09240401GP 2042395-001+889880 SED09280402GA 2042395-001+889072 SED09280403GA 2042395-001+889072 SED09280404GA 2042395-001+905096 SED09280405GA 2042395-001+893818 SED09280406GA 2042395-001+889074 SED09280407GA 2042395-001+895722 SED09280409GA 2042395-001+895148 SED09280412GA 2042395-001+895722 SED09280415GA 2042395-001+895726 SED09280417GA 2042395-001+895726 SED09280418GA 2042395-001+895148 SED09280421GA 2042395-001+895722 SED09280424GA 2042395-001+889074 SED09280425GA 2042395-001+895148 SED09280430GA…
FDA’s list runs to 1,383,160 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, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA.
These words name no state.
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 Jun 13, 2014.
- FDA classified it on Jul 21, 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 1,383,160 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.