GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical Systems - Americas, Milwaukee, USA The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications.
FDA Recall Z-2145-2008 · Posted 2008-09-19
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-05-01
Date Terminated2012-01-07
Product Quantity61 (32 US / 29 OUS)
Reason for Recall
The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
Firm Action
GE Field Engineers will visit affected customers to make correction.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Within the US to include: AK, CO, IL, IN, LA, MA, MI, MS, NC, NJ, NY, PA, SC,TN, UT, VA, WA, and WI. OUS to include: Australia, Brazil, Canada, Colombia, Korea, Mexico, Philippines, Taiwan, Thailand, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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