PlainRecordsFDA · Medical device recall
GE LightSpeed VCT / Light Speed VCT standard configuration… and 4 more products
- Date posted by the FDA
- May 15, 2007
- Status
- Terminated
- Filed by
- GE Healthcare
- Reason
- Oil may leak onto the port window of the CT tube and may result in image artifacts that could lead to misdiagnosis.
- 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
5 products in this recall
GE LightSpeed VCT / Light Speed VCT standard configuration…
- Product
- GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System.
- Quantity
- 1,172
- Codes and lots
- All serial numbers
- Recall started
- Dec. 21, 2006
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0802-2007
GE LightSpeed VCT Select / LightSpeed Pro32…
- Product
- GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system.
- Quantity
- 158
- Codes and lots
- All serial numbers
- Recall started
- Dec. 21, 2006
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0803-2007
GE LightSpeed Pro 16 (100kW/80kW) Models 2357739…
- Product
- GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739-7 and 2357739-8, CT Scanner systems
- Quantity
- 462
- Codes and lots
- All serial numbers
- Recall started
- Dec. 21, 2006
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0804-2007
GE LightSpeed Xtra / GE LightSpeed RT Pro 16…
- Product
- GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems.
- Quantity
- 21
- Codes and lots
- All serial numbers
- Recall started
- Dec. 21, 2006
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0805-2007
GE Discovery VCT…
- Product
- GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3.
- Quantity
- 4
- Codes and lots
- All serial numbers
- Recall started
- Dec. 21, 2006
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Other
- What the company told customers
- 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.
- Recall number
- Z-0806-2007
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0802-2007, Z-0803-2007, Z-0804-2007, Z-0805-2007, Z-0806-2007. The agency record governs; check it and the company before acting.