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

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Safety Assessment

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

Product Details

Model Numbers
2030360-001
VU2
VU4
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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