—#51228

Product

GE Healthcare-Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K040444
Affected lot / code info: 00000249264MR3, 00000257756MR7, 00000255196MR8, 00000246630MR8, 00000259107MR1, 00000248178MR6, 00000257451MR5, 00000256200MR7, 00000260871MR9, 00000252451MR0, 00000259108MR9, 00000254480MR7, 00000254482MR3, 00000256198MR3, 00000249263MR5, 00000250755MR6, 00000251090MR7, 00000GE0131001, 00000GE0213040, 00000254375MR9, 00000GE0205028, 00000GE0210034, 00000227995MR8, 00000GE0212037, 00000GE0226049, 00000GE0410083, 00000260871MR9, 00000GE0234057, 00000GE0123041, 00000GE0302068

Why it was recalled

To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the software.

Root cause (FDA determination)

Other

Action the firm took

The corrective action is already completed and all customers have been notified via a personal visit to each site, to install a software patch beginning June, 2006.

Recalling firm

Firm: GE Medical Systems LLC
Address: 3200 N Grandview Blvd, Waukesha, Wisconsin 53188-1693

Distribution

Distribution pattern: Worldwide, including USA, China, Finland, Germany, Israel, Italy, Korea, Spain, and Taiwan.

Timeline

Recall initiated: 2006-06-01
Posted by FDA: 2007-05-18
Terminated: 2008-02-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #51228. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.