CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric…
Medical device recall Z-0727-2020. Published in FDA’s Enforcement Report on Jan 1, 2020.
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 Jan 1, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 10661 units 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?
When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other nonmedical information.
10661 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: SGJ14180008GP SGJ14180009GP SGJ14220011GA SGJ14220014GA SGJ14220015GA SGJ14220016GA SGJ14220017GA SGJ14220019GA SGJ14220023GA SGJ14220024GA SGJ14220026GA SGJ14220027GA SGJ14220029GA SGJ14220032GA SGJ14220033GA SGJ14220034GA…
Every code shown here, 1,990 characters
Serial Numbers: SGJ14180008GP SGJ14180009GP SGJ14220011GA SGJ14220014GA SGJ14220015GA SGJ14220016GA SGJ14220017GA SGJ14220019GA SGJ14220023GA SGJ14220024GA SGJ14220026GA SGJ14220027GA SGJ14220029GA SGJ14220032GA SGJ14220033GA SGJ14220034GA SGJ14220037GA SGJ14220038GA SGJ14220041GA SGJ14430047GA SGJ14430048GA SGJ14430051GA SGJ14430052GA SGJ14430055GA SGJ14430057GA SGJ14430060GA SGJ14430061GA SGJ14440067GA SGJ14440071GA SGJ14440073GA SGJ14440077GA SGJ14440078GA SGJ14440081GA SGJ14440082GA SGJ14440085GA SGJ14440086GA SGJ14450092GA SGJ14450094GA SGJ14450095GA SGJ14450096GA SGJ14450097GA SGJ14450098GA SGJ14450099GA SGJ14450101GA SGJ14450104GA SGJ14450105GA SGJ14450106GA SGJ14450107GA SGJ14450109GA SGJ14450141GA SGJ14450142GA SGJ14450145GA SGJ14450146GA SGJ14450147GA SGJ14450152GA SGJ14450155GA SGJ14450156GA SGJ14450159GA SGJ14450161GA SGJ14450162GA SGJ14450163GA SGJ14450164GA SGJ14450168GA SGJ14450170GA SGJ14450171GA SGJ14450173GA SGJ14450176GA SGJ14450177GA SGJ14450179GA SGJ14480180GA SGJ14480181GA SGJ14480182GA SGJ14480183GA SGJ14480184GA SGJ14480186GA SGJ14480187GA SGJ14480188GA SGJ14480189GA SGJ14480192GA SGJ14480193GA SGJ14480194GA SGJ14480195GA SGJ14480196GA SGJ14480197GA SGJ14480198GA SGJ14490200GA SGJ14490202GA SGJ14490211GA SGJ14490213GA SGJ14490214GA SGJ14490215GA SGJ14490225GA SGJ14490230GA SGJ14490231GA SGJ14490232GA SGJ14490233GA SGJ14490235GA SGJ14490236GA SGJ14490237GA SGJ14490238GA SGJ14490239GA SGJ14490240GA SGJ14490241GA SGJ14490242GA SGJ14490243GA SGJ14490244GA SGJ14490246GA SGJ14490247GA SGJ14490248GA SGJ14490249GA SGJ14490251GA SGJ14490252GA SGJ14490253GA SGJ14490254GA SGJ14490255GA SGJ14490256GA SGJ14490257GA SGJ14490258GA SGJ14490260GA SGJ14490263GA SGJ14490265GA SGJ14490266GA SGJ14490267GA SGJ14490269GA SGJ14490272GA SGJ14490275GA SGJ14490276GA SGJ14490277GA SGJ14490278GA SGJ14490284GA SGJ14490287GA SGJ14490288GA SGJ14500289GA SGJ14500290GA SGJ14500291GA SGJ14500292GA SGJ14500293GA SGJ14500294GA SGJ14500295GA SGJ14500296GA SGJ14500297GA…
FDA’s list runs to 157,761 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.
These words name no state.
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 Nov 12, 2019.
- FDA classified it on Dec 20, 2019.
- FDA’s Enforcement Report published it on Jan 1, 2020.
- FDA terminated it on Mar 2, 2026.
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.
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 157,761 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.