GE Medical Systems recalled 29,225 MAC VU360 Acquisition Trunk Cable and Module Holder devices worldwide. The defect can occur when a user inserts the Acquisition Module incorrectly, causing excessive bending and wear of the Acquisition Trunk Cable. A damaged sheath or exposed wires may appear. If a damaged cable is not identified and removed from service, it can overheat. Stop use immediately and
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.
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
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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.
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.
This recall is not described as part of a broader industry pattern in the provided information.
Hospitals and clinics could face downtime and device replacement costs. Patients could be exposed to overheating hazards if a damaged cable remains in service.
Serial numbers are printed on the device label near the model, and the UDI code appears on the equipment documentation.
Recall processing and potential replacement or repair will follow GE recall protocols, typically weeks to months.
Keep the recall letter, photos of the device, serial numbers, repair/replacement communications, and correspondence with GE Medical Systems for records
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
No injuries or incidents have been reported.
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