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.
This recall has been terminated (originally issued September 22, 2006).
- Company
- General Electric Med Systems Llc
- Recall Initiated
- May 15, 2006
- Posted
- September 22, 2006
- Terminated
- May 25, 2007
- Recall Number
- Z-1304-06
- Quantity
- 1,289
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
Worldwide, including USA, Puerto Rico, Canada, France, Germany, Indonesia, Italy, Japan, Jordan, Kuwait, Macedonia, Panama, Russia, Saudi Arabia, Singapore, and United Kingdom.
Lot / Code Info
All serial numbers affected
Root Cause
Other
Action Taken
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.