Recalls / —

—#49786

Product

GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K040372

Affected lot / code info

All serial numbers

Why it was recalled

Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.

Root cause (FDA determination)

Other

Action the firm took

A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.

Recalling firm

Firm

GE Healthcare

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

Worldwide Distribution: USA in the following states and locations: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, Guam and Puerto Rico. Foreign countries include ; Albania, Algeria, Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Canada, Chile, China, Columbia, Czechoslovakia, Denmark, Finland, France, Germany, Great Britain, Greece, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, and Vietnam

Timeline

Recall initiated

2006-12-21

Posted by FDA

2007-05-15

Terminated

2012-07-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #49786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.