Recall archive / FDA device enforcement
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model... — FDA record Z-0231-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 22, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU4
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- GE Medical Systems, LLC
- Quantity
- 29,225 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0231-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 VU222010078SA VU222010084SA VU222010096SA VU222010097SA VU220510054SA VU220510083SA VU220510084SA VU220310048SA VU220310071SA VU222060140SA VU222070017SA VU222070028SA VU222070081SA VU222070082SA VU222070087SA VU222070124SA VU222070131SA VU222070133SA VU222070135SA VU222070137SA VU222070140SA VU222070142SA VU222070143SA VU222070145SA VU222120095SA VU222340060SA VU222350205SA VU223240164SA VU223240206SA VU420290059SA VU421350234SA VU221490032SA VU223220131SA VU421380150SA VU421380154SA VU422480255SA VU422510026SA VU422510055SA VU422510063SA VU221380182SA VU420300098SA VU420300099SA VU420300106SA VU422010046SA VU422010051SA VU422010064SA VU422010111SA VU422020010SA VU422020016SA VU423050025SA VU423050026SA VU423050028SA VU423050030SA VU423050044SA VU423050045SA VU423050046SA VU423050047SA VU423050048SA VU423050079SA VU423050081SA VU423050082SA VU423050083SA VU423050085SA VU423050089SA VU423050090SA VU423050091SA VU422350040SA VU422350042SA VU422350043SA VU422350045SA VU423050078SA VU223110237SA VU223110246SA VU222230077SA VU222240008SA VU222240009SA VU223170029SA VU223170064SA VU223170066SA VU223170067SA VU223110337SA VU220440024SA VU220440038SA VU221130056SA VU223180099SA VU420300102SA VU420300120SA VU420300122SA VU422120361SA VU422120364SA VU422120367SA VU422120372SA VU422120376SA VU422120378SA VU422120380SA VU220020035SA VU223110352SA VU223110358SA VU221290085SA VU221290092SA VU221290095SA VU221290096SA VU221290102SA VU222020009SA VU220420030SA VU220420047SA VU220420075SA VU220420091SA VU220420095SA VU220430043SA VU220430051SA VU220430053SA VU223130175SA VU222260377SA VU222260380SA VU221260142SA VU221270082SA VU219500036SA VU219500046SA VU220110020SA VU220120003SA VU422130033SA VU421340033SA VU421340063SA VU421340068SA VU421340082SA VU421340083SA VU421340087SA VU421340099SA VU421340101SA VU421340111SA VU421340112SA VU422120362SA VU422120365SA VU422120368SA VU422120374SA VU422350022SA VU422350053SA VU422350057SA VU422350061SA VU422350094SA VU422350095SA VU422360043SA VU422360044SA VU422360045SA VU422360050SA VU221150199SA VU221150200SA VU221150201SA VU421340051SA VU421340069SA VU222460103SA VU222460107SA VU222460110SA VU222020021SA VU222020036SA VU222340083SA VU222500191SA VU222500201SA VU223250148SA VU222500213SA VU222470209SA VU222480039SA VU222480053SA VU223230189SA VU221150092SA VU221150098SA VU221150110SA VU221150144SA VU221150145SA VU221150148SA VU221380276SA VU222190066SA VU222190082SA VU222190087SA VU222190088SA VU222190103SA VU222190112SA VU220510191SA VU220520046SA VU220520050SA VU220520054SA VU220520053SA VU420190061SA VU420170058SA VU420190059SA VU420190062SA VU420190057SA VU220210112SA VU220030017SA VU220030029SA VU220030032SA VU220030033SA VU222260134SA VU222260191SA VU220430113SA VU220430128SA VU223180074SA VU223180077SA VU221050137SA VU221050157SA VU221050161SA VU221060005SA VU221060010SA VU221060016SA VU220510117SA VU220510126SA VU221260106SA VU423220231SA VU423230009SA VU423230017SA VU423230018SA VU423230020SA VU423230021SA VU423230019SA VU419460042SA VU419470012SA VU419470013SA VU419470015SA VU419470016SA VU419470017SA VU423220238SA VU423230008SA VU423230011SA VU423230013SA VU423230014SA VU423230015SA VU423230016SA VU423230022SA VU423230023SA VU423230024SA VU221160057SA VU221520030SA VU221520031SA VU221520043SA VU222020073SA VU222020145SA VU222030010SA VU222240038SA VU222240049SA VU222240054SA VU223130084SA VU222350091SA VU222090014SA VU222290043SA VU220210088SA VU220510002SA VU223180075SA VU423170156SA VU423180259SA VU423190136SA VU423190138SA VU423190139SA VU423190140SA VU423180259SA-2 VU222470075SA VU223100250SA VU223100365SA VU223100369SA VU220210118SA VU220210130SA VU220220024SA VU220220030SA VU220220031SA VU220220033SA VU220300069SA VU220300083SA VU220300084SA VU220300091SA VU220430129SA VU220440032SA VU221110205SA VU221120156SA VU221140021SA VU221330077SA VU222110040SA VU222120110SA VU222120111SA VU222240383SA VU222250031SA VU222450241SA VU222450249SA VU222230224SA VU222230253SA VU222250462SA VU222260125SA VU222330100SA VU222450236SA VU222450243SA VU222450245SA VU222450250SA VU222500194SA VU222500208SA VU223130145SA VU223300033SA VU420380073SA VU420370076SA VU420380007SA VU420370080SA VU420370081SA VU420370082SA VU420380001SA VU420380004SA VU420380006SA VU420380008SA VU420380021SA VU420380083SA VU420380084SA VU420380034SA VU420380038SA VU420400001SA VU420460142SA VU420460147SA VU420460149SA VU420460150SA VU420460155SA VU420460156SA VU420460157SA VU420460160SA VU420460161SA VU420460162SA VU420460164SA VU420460167SA VU420460177SA VU420460183SA VU420460184SA VU420470031SA VU420480009SA VU420480011SA VU420480016SA VU420480026SA VU420480029SA VU420480031SA VU420480032SA VU221120164SA VU221120240SA VU422050089SA VU422050111SA VU422050119SA VU422060121SA VU422070088SA VU422070091SA VU422070094SA VU422070095SA VU422070098SA VU422070099SA VU422070101SA VU422070103SA VU422070104SA VU422070105SA VU422130001SA VU422130006SA VU422130021SA VU422130026SA VU422130034SA VU422130042SA VU422130043SA VU422130047SA VU422130048SA VU422130107SA VU422130108SA VU420280001SA VU420280002SA VU420280003SA VU420280004SA VU420280006SA VU420280014SA VU222030052SA VU223100042SA VU223100066SA VU223100070SA VU223100072SA VU223100076SA VU223100078SA VU223100079SA VU223100083SA VU223100095SA VU421510157SA VU421510176SA VU421510184SA VU422010031SA VU422010032SA VU422010033SA VU422010038SA VU422010039SA VU422010040SA VU422010091SA VU422050015SA VU422050110SA VU422050118SA VU422060086SA VU422070089SA VU422070090SA VU422070092SA VU422070093SA VU422070096SA VU422070097SA VU422070100SA VU422070102SA VU422070153SA VU422070154SA VU422070155SA VU422070157SA VU422070158SA VU422070159SA VU422070162SA VU221150120SA VU220210119SA VU220220021SA VU220220025SA VU223250129SA VU423240024SA VU222080039SA VU222080049SA VU222080076SA VU222080078SA VU420380023SA VU420380080SA VU420380087SA VU420380071SA VU420380081SA VU420380086SA VU420220094SA VU420230002SA VU420230004SA VU420230005SA VU420230008SA VU420250060SA VU420250112SA VU420250116SA VU420260100SA VU420260106SA VU420260110SA VU420260118SA VU420460197SA VU420470034SA VU420480006SA VU420480010SA VU420480013SA VU420480017SA VU420480020SA VU420480021SA VU420480022SA VU420480023SA VU420480024SA VU420480028SA VU420380025SA VU420380033SA VU420380039SA VU420380041SA VU420380042SA VU420380043SA VU420380049SA VU420380050SA VU420380052SA VU420390059SA VU420460163SA VU420460170SA VU420460176SA VU420460187SA VU420480008SA VU420480037SA VU420480038SA VU420480039SA VU421430001SA VU421440027SA VU421440032SA VU421450150SA VU421450151SA VU421450162SA VU421450163SA VU421450164SA VU421450165SA VU421450166SA VU421460003SA VU421460005SA VU421460012SA VU421460014SA VU421460015SA VU422410221SA VU223030001SA VU223030002SA VU223030010SA VU422130005SA VU422130010SA VU422130025SA VU422130029SA VU422130035SA VU422130037SA VU221110199SA VU221120023SA VU221120034SA VU222350149SA VU222350152SA VU222350197SA VU222350198SA VU222350199SA VU222350200SA VU222350201SA VU222350203SA VU222350204SA VU222350210SA VU222350211SA VU222350212SA VU222360001SA VU222360002SA VU222360003SA VU222360004SA VU222360005SA VU222360006SA VU222360007SA VU222360008SA VU222360010SA VU222360011SA VU222360012SA VU222360013SA VU222360014SA VU222360015SA VU222360021SA VU222360022SA VU222360023SA VU222360024SA VU222360025SA VU222360026SA VU222360028SA VU222360030SA VU222360031SA VU222400128SA VU222400133SA VU222400181SA VU222400183SA VU222190089SA VU222190101SA VU222190111SA VU222190115SA VU223160176SA VU223160254SA VU223160255SA VU223320093SA VU222260367SA VU222280026SA VU222280049SA VU222280069SA VU222280071SA VU222280075SA VU222320089SA VU222320093SA VU222320099SA VU222360281SA VU222380149SA VU222480241SA VU223060006SA VU223320122SA VU223320133SA VU223320136SA VU223320157SA VU223320171SA VU221150107SA VU222200088SA VU222210092SA VU222220192SA VU222220266SA VU222410094SA VU222410063SA VU222410107SA VU222460235SA VU222460254SA VU222460142SA VU222470096SA VU222470116SA VU222470122SA VU222470128SA VU222470130SA VU222470138SA VU222470140SA VU222470141SA VU222500092SA VU222500085SA VU222500073SA VU222510016SA VU222510078SA VU220440050SA VU220440051SA VU220380091SA VU220380094SA VU220390001SA VU220390014SA VU220390015SA VU221370079SA VU221370111SA VU221380009SA VU221380013SA VU221380014SA VU222390177SA VU222390178SA VU222390192SA VU222390199SA VU222390208SA VU222390209SA VU223120148SA VU223120201SA VU223120202SA VU221380216SA VU221380221SA VU221380223SA VU221290118SA VU221320086SA VU221320123SA VU221320221SA VU221330085SA VU221330128SA VU221350010SA VU221350133SA VU222030012SA VU222200026SA VU222200045SA VU222200042SA VU222200106SA VU222500102SA VU222510244SA VU222510206SA VU222520030SA VU222520037SA VU223250132SA VU222480105SA VU222480187SA VU222510219SA VU222510228SA VU223050007SA VU223050114SA VU223050118SA VU223050119SA VU223050127SA VU223050132SA VU223050144SA VU223050146SA VU223050148SA VU223050150SA VU223050154SA VU223050160SA VU223300047SA VU223300319SA VU220080029SA VU220090015SA VU220090108SA VU220090109SA VU223220202SA VU223230163SA VU223230223SA VU221110103SA VU220440088SA VU220440093SA VU219420002SA VU221080218SA VU219410061SA VU219410060SA VU219410062SA VU222240314SA VU222240328SA VU222240340SA VU222240345SA VU222240346SA VU222240347SA VU222240352SA VU221180051SA VU221180053SA VU221180075SA VU221180076SA VU221180077SA VU221210103SA VU221210164SA VU221210165SA VU221210167SA VU221210177SA VU221210181SA VU221210193SA VU221240161SA VU221240169SA VU222210071SA VU219380008SA VU219380009SA VU219380017SA VU221050132SA VU221050144SA VU221050041SA VU223110443SA VU421440013SA VU421440038SA VU421490061SA VU421490064SA VU421490073SA VU421490080SA VU422290014SA VU421380140SA VU421380159SA VU420260130SA VU219370046SA VU219370049SA VU219380005SA VU219380006SA VU219280016SA VU219280031SA VU219280036SA VU219290004SA VU219290028SA VU219290030SA VU219290035SA VU219290036SA VU219290047SA VU219330004SA VU222380331SA VU223250139SA VU222240197SA VU222240225SA... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Oct 29, 2025
- Recall initiation date
- Aug 22, 2025
- Center classification date
- Oct 22, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.