GE Healthcare, CARESCAPE Monitor B850
Medical device recall Z-2201-2013. 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 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 16 states named
- 636 (53 US, 583 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 an issue associated with the CARESCAPE Monitor B850 when used with the iCentral network. The iCentral must have the alarm management software license (L-NETM-00) and the alarm limit change option enabled to experience this issue. When changing the HR, SpO2 or Invasive pressure alarm limits from the iCentral over the network, the alarm priority on th
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
636 (53 US, 583 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Number 6617967 6617968 6617969 6619157 6619158 6619159 6619160 6626633 6626634 6637287 6660104 6693980 6720596 6720597 6720598 6720599 6739266 CZC0044VY8 CZC0044VYL CZC0044VYY CZC0044VZ1 CZC0044VZ5 CZC0044VZ6 CZC0044VZ7 CZC0044VZ8…
Every code shown here, 1,998 characters
Serial Number 6617967 6617968 6617969 6619157 6619158 6619159 6619160 6626633 6626634 6637287 6660104 6693980 6720596 6720597 6720598 6720599 6739266 CZC0044VY8 CZC0044VYL CZC0044VYY CZC0044VZ1 CZC0044VZ5 CZC0044VZ6 CZC0044VZ7 CZC0044VZ8 CZC0044VZB CZC0070P7B CZC0070P7G CZC0133FMM CZC0133FMS CZC0133FN7 CZC0182JL2 CZC0182JL8 CZC02211YN CZC0249CL3 CZC0249CL5 CZC0249CL7 CZC0249CLF CZC0249CLK CZC03336CT CZC03336D1 CZC03336D6 CZC0334KJ5 CZC0334KJ6 CZC0366ZR0 CZC0468W4H CZC1027W82 CZC1027W85 CZC1027W86 CZC1027W8C CZC1129Z65 CZC116B2N7 CZC9313455 CZC0016T0H CZC0016T0T CZC0044VY7 CZC0044VY9 CZC0044VYD CZC0044VYM CZC0044VYP CZC0044VYQ CZC0044VYR CZC0044VYV CZC0044VZ2 CZC0044VZ9 CZC0044VZC CZC0133FMJ CZC0207NVR CZC0207NVS CZC02211YD CZC02211YG CZC02211YT CZC0249CLJ CZC0322T5K CZC0334KJM CZC0369HKQ CZC1069WFK CZC1069WFT CZC1129Z6D CZC1129Z6Y CZC1129Z73 CZC94890S5 CZC94890S7 CZC94890SD CZC0322T5G CZC0322T5J CZC0070P7S CZC0133FN4 CZC02213JC CZC02213JF CZC02213JG CZC02213JJ CZC0526KZ1 CZC1069WF7 CZC1069WF9 CZC1129Z63 CZC1129Z6B CZC1129Z6C CZC1129Z74 CZC94890S1 CZC94890S8 CZC94890SC CZC94890SK CZC0070P82 CZC03336C8 CZC0107DR3 CZC0070P7X CZC0107DQ7 CZC0182JL7 CZC0182JLF CZC0207NVP CZC0334KJF CZC0474PTP CZC0474PVK CZC1027W8M CZC1069WF5 CZC1069WFB CZC1129Z68 CZC1129Z6R CZC1129Z6Z CZC0107DQ3 CZC0107DQR CZC0334KJJ CZC1027W7W CZC1069WF1 CZC1129Z64 CZC0107DQ6 CZC0107DQ8 CZC0334KJH CZC0334KJR CZC0474PTK CZC0526KZ6 CZC0526KZ8 CZC0107DQ9 CZC0107DR4 CZC02213J9 CZC02213JL CZC03336CJ CZC0468W53 CZC1129Z6J CZC1129Z6T CZC0107DQ1 CZC0107DQB CZC0107DQC CZC0107DQZ CZC03336CN CZC0366ZQT CZC0369HL1 CZC0474PV0 CZC0526KYN CZC1069WF3 CZC1129Z76 CZC0133FNB CZC02211YF CZC02211YH CZC0369HL2 CZC0232J70 CZC0182JL4 CZC0133FMY CZC0133FN0 CZC0133FN2 CZC02211YB CZC02211YQ CZC0249CLC CZC03336CM CZC0334KJC CZC0369HLL CZC0468W46 CZC0468W4Q CZC0468W4R CZC1027W8B CZC1027W8N CZC0249CLL CZC0044VYK CZC0474PTY CZC0044VZ4 CZC0070P78 CZC0070P7L CZC0070P7Q CZC0070P7T CZC0070P7V CZC0070P80 CZC0107DQK CZC0107DR1 CZC0207NW0…
FDA’s list runs to 6,883 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 CA, CO, CT, HI, IL , IA, KY, LA, MA, MI, NE, NY,OH, OK, TX, and WI, and the countries of UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF SERBIA, PORTUGAL, POLAND, PARAGUAY, NORWAY, NETHERLANDS, NEPAL, MEXICO, MALAYSIA, KUWAIT, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, COSTA RICA, COLOMBIA, CHINA, CHILE, CANADA, BOSNIA AND HERZEGOVINA, BELGIUM, BAHRAIN, AUSTRIA, and AUSTRALIA.
The states and territories these words name
16 states and territories.
Every one of them
- California
- Colorado
- Connecticut
- Hawaii
- Iowa
- Illinois
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Nebraska
- New York
- Ohio
- Oklahoma
- Texas
- Wisconsin
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, 2011.
- FDA classified it on Sep 16, 2013.
- FDA’s Enforcement Report published it on Sep 25, 2013.
- FDA terminated it on Oct 25, 2013.
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 6,883 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.