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Terminated

The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.

FDA Recall Z-0507-2007 · Posted 2007-02-15

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeJAK
Date Initiated2006-12-08
Date Terminated2007-11-30
Product Quantity1,256 units

Reason for Recall

When the manual cradle release feature on the table is used to move a patient out of the gantry, a discrepancy of up to 6mm between the numerical display on the gantry and the actual position of the table could be introduced.

Firm Action

A Product Safety Advisory Notice, dated December 8, 2006, was issued to all customers informing them of the safety issue and production correction. Customers are advised to operate the CT cradle as intended with the system''s electronic controls. If a critical need arises to release the cradle during a radiation therapy simulation scan, they are advised to independently verify patient position prior to marking the patient for therapy to avoid the potential inaccuracy. A software update will be installed to correct this problem by a GE representative.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Puerto Rico, Albania, Argentina, Austria, Australia, Belarus, Belgium, Bulgaria, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Great Britain, Greece, Guam, Hong Kong, Honduras, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia , Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain , Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Venezuela, Vietnam, and Yugoslavia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040372LIGHTSPEED 7.0 CT SCANNER SYSTEMGe Medical Systems, LLC · 2004-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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