MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph
Medical device recall Z-0231-2026. Published in FDA’s Enforcement Report on Oct 29, 2025.
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 Oct 29, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 29,225 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?
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
29,225 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: 00840682125499; Serial Numbers: VU221240028SA VU221250168SA VU222120101SA VU222120114SA VU222120120SA VU222400056SA VU222400070SA VU222480182SA VU421010035SA VU420530073SA VU420530105SA VU420530108SA VU420530109SA VU420530110SA…
Every code shown here, 2,000 characters
UDI-DI: 00840682125499; Serial Numbers: VU221240028SA VU221250168SA VU222120101SA VU222120114SA VU222120120SA VU222400056SA VU222400070SA VU222480182SA VU421010035SA VU420530073SA VU420530105SA VU420530108SA VU420530109SA VU420530110SA VU421010007SA VU421010008SA VU421010009SA VU421010010SA VU421010012SA VU421010021SA VU421010029SA VU421010040SA VU421010042SA VU422410219SA VU422410220SA VU220500166SA VU220500167SA VU222250167SA VU222250175SA VU423290038SA VU423290039SA VU423290063SA VU423290068SA VU221500205SA VU221500215SA VU221500216SA VU221500218SA VU221300012SA VU221320090SA VU221330009SA VU221330012SA VU221330013SA VU221120005SA VU221490009SA VU221490015SA VU221490031SA VU221490033SA VU221490038SA VU221490043SA VU221490113SA VU421250084SA VU420290004SA VU420290052SA VU221350037SA VU421340025SA VU421340038SA VU421340117SA VU421340120SA VU421340127SA VU421340131SA VU421340139SA VU421340142SA VU421340163SA VU421350169SA VU421350174SA VU421350179SA VU421350201SA VU421350206SA VU421350207SA VU421350209SA VU421350210SA VU421350211SA VU421350213SA VU421350214SA VU421350216SA VU421350223SA VU421350225SA VU421350227SA VU421350228SA VU421350231SA VU421350233SA VU421350239SA VU421350248SA VU421350249SA VU421350251SA VU421350252SA VU421350253SA VU421350267SA VU421350268SA VU421350269SA VU421350271SA VU421350272SA VU421350273SA VU421350275SA VU421350279SA VU421350280SA VU421350282SA VU421350287SA VU421500058SA VU221010086SA VU221010089SA VU221020043SA VU221020044SA VU221020046SA VU221020047SA VU221020048SA VU221020051SA VU221020052SA VU221020054SA VU221020055SA VU221020056SA VU220100042SA VU220100050SA VU220100051SA VU220100055SA VU220100069SA VU220100073SA VU220100074SA VU220100076SA VU220100077SA VU220100079SA VU220100080SA VU220100082SA VU222390186SA VU221490003SA VU221490006SA VU221490010SA VU221490011SA VU221490012SA VU221490013SA VU221490014SA VU221490016SA VU221490021SA VU221490024SA VU221490029SA VU221490044SA VU221110086SA VU221040087SA VU222010022SA VU222010074SA…
FDA’s list runs to 409,202 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) and OUS (foreign/Global) to countries of: Australia, Austria, Bahrain, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Republic of, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, Sweden, Switzerland, Thailand, United Arab Emirates, and United Kingdom.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Aug 22, 2025.
- FDA classified it on Oct 22, 2025.
- FDA’s Enforcement Report published it on Oct 29, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Medical Systems, 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 409,202 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.