GE Healthcare (China) Co., Ltd.: Device Recall

Recall #Z-0550-2025 · 10/24/2024

Class II: Risk

Recall Details

Recall Number: Z-0550-2025
Classification: Class II
Product Type: Device
Recalling Firm: GE Healthcare (China) Co., Ltd.
Status: Ongoing
Date Initiated: 10/24/2024
Location: Beijing, China
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 956 systems

Reason for Recall

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

Product Description

GE Proteus XR/A radiographic system

Distribution Pattern

Worldwide - US Nationwide distribution.

Other Recalls by GE Healthcare (China) Co., Ltd.

Class II: Risk 01/31/2025

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Class II: Risk 01/31/2025

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Class II: Risk 01/31/2025

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Class II: Risk 01/31/2025

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.
Class II: Risk 01/31/2025

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

View all recalls by GE Healthcare (China) Co., Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.