General Electric Med Systems LLC GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting 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
GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting 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 affected
Products Sold
All serial numbers affected
General Electric Med Systems LLC is recalling GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting o due to Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the pr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam
Recommended Action
Per FDA guidance
An Important Notice for Precision 500D, dated 11/24/2005 was hand delivered to all customers beginning 05/15/06, by GE field service engineers at the time they were to perform the correction to the device.
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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026