General Electric Med Systems LLC Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system.
Brand
General Electric Med Systems LLC
Lot Codes / Batch Numbers
all serial numbers
Products Sold
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General Electric Med Systems LLC is recalling Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision due to Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
Recommended Action
Per FDA guidance
An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification.
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