Proteus XR/A Radiographic System (GE Healthcare) – wall stand cable risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Proteus XR/A radiographic system
Brand
GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China
Lot Codes / Batch Numbers
UDI-DI: 00840682120777
Products Sold
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GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China is recalling GE Proteus XR/A radiographic system due to 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 Prev. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/24/24 was sent to customers. Actions to be taken by Customer/User " You can continue to use the system for table exams without limitations. " You can continue to use the wall stand for exams where the patient does not have any part of their body underneath the bucky. " Do not perform exams where the patient has any body part underneath the bucky until the Wall Stand steel cable has been inspected and if necessary, has been replaced. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to RECALL.17148@gehealthcare.com GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026