GE Healthcare, LLC Proteus XR/a (SlOK : K993090) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Proteus XR/a (SlOK : K993090)
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
Products Sold
console part number 5441870) and (console spare part numbers 5462233, 5462233-R, 5761170, 5462233-H)
GE Healthcare, LLC is recalling Proteus XR/a (SlOK : K993090) due to Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
Recommended Action
Per FDA guidance
GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. 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- 800-437-1171or 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