BrightSpeed Excel/Edge/Elite Select Computed Tomography X-Ray System. For head, whole body X-ray Computed Tomography app

FDA device recall Z-0286-2011 · posted 2011-03-01 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Failure to properly document the CTDI in the Technical Reference or User Manual.

Action taken

Planned action(s) to repair defect or to bring product into compliance: GE Healthcare will bring the Technical Reference Manual into compliance by correcting the noncompliance in forward production and the installed base units. This will be accomplished by delivering an "Important Electronic Product Radiation Warning" letter and a TRM addendum which contains the corrected information to customers. This will be carried out via a Field Modification Instruction IFMI 229251 planned to be released in October, 2010 with an estimated completion date of April, 2011. The letter identifies the affected product and describes the defect and related hazards. It also asks customers to refer to the TRM addendum for the scan time accuracy, the helical scan exposure time, and the CTDI adjustment factors for 4 and 8 slices. Contact information is also provided.

Root cause

Radiation Control for Health and Safety Act

Status

Terminated

Product code

JAK

Quantity affected

103 units

Distribution

Nationwide Distribution

Date initiated

2010-05-01

Date posted

2011-03-01

Date terminated

2013-12-05

Location

Waukesha, WI