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.
This recall has been terminated (originally issued February 14, 2006).
- Company
- General Electric Med Systems Llc
- Recall Initiated
- December 30, 2004
- Posted
- February 14, 2006
- Terminated
- February 21, 2006
- Recall Number
- Z-0220-05
- Quantity
- 921
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
Distribution
globally
Lot / Code Info
all serial numbers
Root Cause
Other
Action Taken
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.
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