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Revolution ACT LMBRecalls & reported problems

GE Hualun Medical Systems Co., Ltd · Revolution ACT designated medical device for Cannon Tube · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 20, 2025Open, Classified

    GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.

    Z-2303-2025 · Root cause: Equipment maintenance · FDA record ↗

  2. Jun 2, 2022Open, Classified

    As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.

    Z-1511-2022 · Root cause: Error in labeling · FDA record ↗

Other System, x-ray, tomography, computed devices

All System, x-ray, tomography, computed devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.