HIGH

GE Medical Systems Recalls Electrocardiograph Due to Overheating Hazard

GE Medical Systems recalled 29,225 units of the MAC VU360 Acquisition Trunk Cable and Module Holder on August 22, 2025. Users may incorrectly place the Acquisition Module, leading to cable damage and potential overheating. Affected devices were distributed globally, including the U.S. and several other countries.

Quick Facts at a Glance

Recall Date
August 22, 2025
Hazard Level
HIGH
Brand
GE Medical Systems
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall involves the MAC VU360 Acquisition Trunk Cable and Module Holder, Model Number 2030360-001, Product Codes VU2 and VU4. The devices were distributed worldwide, including the U.S., Australia, Canada, and European countries.

The Hazard

Improper placement of the Acquisition Module can cause excessive bending and wear of the Acquisition Trunk Cable. If not identified, damaged cables could overheat during use, posing a significant risk of electrical hazards.

Reported Incidents

There have been no reported injuries or deaths associated with this recall. However, the potential for overheating presents a serious risk.

What to Do

Stop using the device immediately. Contact GE Medical Systems or your healthcare provider for further instructions on how to proceed with the recall.

Contact Information

For more information, contact GE Medical Systems at 1-800-XXX-XXXX or visit their website at www.gehealthcare.com.

Key Facts

  • Recalled product: GE MAC VU360 Acquisition Trunk Cable and Module Holder
  • Recall date: August 22, 2025
  • Quantity: 29,225 units
  • Hazard: Risk of overheating if damaged
  • Immediate action required: Stop use and contact GE Medical Systems
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICAL

Product Classification

Product TypeElectrocardiograph
Sold At
Multiple Retailers

Product Details

Model Numbers
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 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VU219490009SA VU220030013SA VU223300320SA VU223300321SA VU222250041SA VU223130013SA VU221320087SA VU221320103SA VU221180001SA VU221180022SA VU221180003SA VU221250170SA VU221320163SA VU222190085SA VU222190161SA VU222190051SA VU222190156SA VU222190086SA VU222190136SA VU222190142SA VU222190164SA VU222190173SA VU222190174SA VU222190176SA VU222190178SA VU222220012SA VU222230210SA VU222280035SA VU223110049SA VU223300309SA VU221150140SA VU221180061SA VU221180065SA VU221180068SA VU221180074SA VU221220041SA VU221220219SA VU220260062SA VU220260040SA VU220270063SA VU220270085SA VU220270094SA VU221060133SA VU221270010SA VU221270084SA VU221280076SA VU221280079SA VU221280113SA VU221290136SA VU222270016SA VU222310058SA VU222310071SA VU222340012SA VU222340013SA VU222340
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Lannett Company Recalls Niacin Tablets for Failed Dissolution

Lannett Company, Inc. recalled 46,848 bottles of Niacin Extended-release Tablets on October 10, 2025. The recall follows reports of failed dissolution specifications, which could affect medication effectiveness. Consumers should stop using the product immediately and consult healthcare providers for guidance.

NIACIN
Failed Dissolution
Read more