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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE Medical Systems
- Product type
- Acquisition Trunk Cable and Module Holder for ECG System
- Model numbers
- 2030360-001, VU2, VU4
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 22, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The MAC VU360 is a high-performance, multichannel resting electrocardiograph system. It uses acquisition cables and a module holder to connect and gather signals for cardiac monitoring.
Why This Is Dangerous
Inserting the Acquisition Module into the Holder incorrectly can cause excessive bending of the trunk cable. This can damage the cable sheath or expose wires. A damaged cable may overheat during use.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Hospitals and clinics could face downtime and device replacement costs. Patients could be exposed to overheating hazards if a damaged cable remains in service.
Practical Guidance
How to identify if yours is affected
- Locate MAC VU360 equipment with model 2030360-001
- Check product codes UVU2 and UVU4 (VU2 and VU4)
- Review UDI-DI 00840682125499 and the serial numbers list for affected units
Where to find product info
Serial numbers are printed on the device label near the model, and the UDI code appears on the equipment documentation.
What timeline to expect
Recall processing and potential replacement or repair will follow GE recall protocols, typically weeks to months.
If the manufacturer is unresponsive
- File a complaint with GE Medical Systems recall support
- Contact the FDA if GE does not respond within a reasonable time
How to prevent similar issues
- Train staff on proper insertion of Acquisition Module into the Holder
- Inspect cables for signs of wear before each use
- Set up a robust recall workflow to remove suspect units from service promptly
Documentation advice
Keep the recall letter, photos of the device, serial numbers, repair/replacement communications, and correspondence with GE Medical Systems for records
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Product Details
Model: 2030360-001 Product Codes: VU2 and VU4 Sold worldwide, including US and numerous countries Recall date: 2025-08-22 Reported by: GE Medical Systems, LLC Price: Unknown Sold from: Unknown Sold to: Unknown Remedy: Stop using the device and follow recall instructions
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 29,225 total units recalled
- Global distribution with US and many countries listed
- Model 2030360-001; Product Codes VU2 and VU4
- Hazard potential: cable overheating due to wear and exposed conductors
- Recall date 2025-08-22; Status: Active
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Safety Guide
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