GE OEC Medical Systems, Inc OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System,
Brand
GE OEC Medical Systems, Inc
Lot Codes / Batch Numbers
Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330.
Products Sold
Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330.
GE OEC Medical Systems, Inc is recalling OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, due to During routine service, a cover may have been installed without the required proper lead shielding.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During routine service, a cover may have been installed without the required proper lead shielding.
Recommended Action
Per FDA guidance
Consignees were notified by telephone on 02/09/2007 and told to discontinue use of the units until they could be inspected by GE personnel. GE personnel visited all 8 sites on 02/12/2007.
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