The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.
FDA device recall Z-0507-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- GE Healthcare
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 1,256 units
- Distribution
- Worldwide, including USA, Puerto Rico, Albania, Argentina, Austria, Australia, Belarus, Belgium, Bulgaria, Brazil, Canada, Chile, China, Columbia, Denmark, Finland, France, Germany, Great Britain, Gre
- Date initiated
- 2006-12-08
- Date posted
- 2007-02-15
- Date terminated
- 2007-11-30
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIGHTSPEED 7.0 CT SCANNER SYSTEM (K040372) | Ge Medical Systems, LLC | 2004-03-01 |