ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct…
Medical device recall Z-0725-2020. 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
- 11347 devices 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?
ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
11347 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: Mfg. Lot or Serial # UDI # SEE09020009GA 00840682109260SEE09020009GA SEE09020010GA 00840682109260SEE09020010GA SEE09020011GA 00840682109260SEE09020011GA SEE09020012GA 00840682109260SEE09020012GA SEE09020013GA…
Every code shown here, 1,989 characters
Serial Numbers: Mfg. Lot or Serial # UDI # SEE09020009GA 00840682109260SEE09020009GA SEE09020010GA 00840682109260SEE09020010GA SEE09020011GA 00840682109260SEE09020011GA SEE09020012GA 00840682109260SEE09020012GA SEE09020013GA 00840682109260SEE09020013GA SEE09020015GA 00840682109260SEE09020015GA SEE09020017GA 00840682109260SEE09020017GA SEE09020020GA 00840682109260SEE09020020GA SEE09020022GA 00840682109260SEE09020022GA SEE09020023GA 00840682109260SEE09020023GA SEE09020024GA 00840682109260SEE09020024GA SEE09020027GA 00840682109260SEE09020027GA SEE09020028GA 00840682109260SEE09020028GA SEE09020029GA 00840682109260SEE09020029GA SEE09020030GA 00840682109260SEE09020030GA SEE09020031GA 00840682109260SEE09020031GA SEE09020032GA 00840682109260SEE09020032GA SEE09020033GA 00840682109260SEE09020033GA SEE09020034GA 00840682109260SEE09020034GA SEE09020035GA 00840682109260SEE09020035GA SEE09020036GA 00840682109260SEE09020036GA SEE09020038GA 00840682109260SEE09020038GA SEE09020040GA 00840682109260SEE09020040GA SEE09020042GA 00840682109260SEE09020042GA SEE09020043GA 00840682109260SEE09020043GA SEE09040045GA 00840682109260SEE09040045GA SEE09040046GA 00840682109260SEE09040046GA SEE09040047GA 00840682109260SEE09040047GA SEE09040048GA 00840682109260SEE09040048GA SEE09040050GA 00840682109260SEE09040050GA SEE09040051GA 00840682109260SEE09040051GA SEE09040052GA 00840682109260SEE09040052GA SEE09040053GA 00840682109260SEE09040053GA SEE09040054GA 00840682109260SEE09040054GA SEE09040055GA 00840682109260SEE09040055GA SEE09040058GA 00840682109260SEE09040058GA SEE09040060GA 00840682109260SEE09040060GA SEE09040061GA 00840682109260SEE09040061GA SEE09040062GA 00840682109260SEE09040062GA SEE09040063GA 00840682109260SEE09040063GA SEE09040064GA 00840682109260SEE09040064GA SEE09040066GA 00840682109260SEE09040066GA SEE09040068GA 00840682109260SEE09040068GA SEE09040069GA 00840682109260SEE09040069GA SEE09040071GA 00840682109260SEE09040071GA SEE09040072GA 00840682109260SEE09040072GA SEE09040075GA…
FDA’s list runs to 375,808 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 375,808 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.