FDA · Medical device recall

HiSpeed LXI (2200997) and 23 more products

Jan. 4, 2011

Date posted by the FDA: Jan. 4, 2011
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: A defect with the hardware and software displaying the incorrect dose data.
Distribution pattern: Nationwide Distribution

24 products in this recall

HiSpeed LXI (2200997)

Product: HiSpeed LXI (2200997)
Quantity: 102 total in US
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0744-2011

HiSpeed LX/l (2200997-2)

Product: HiSpeed LX/l (2200997-2)
Quantity: 102 total in US
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0745-2011

HiSpeed DX/I (2201000)

Product: HiSpeed DX/I (2201000)
Quantity: 102 total in US
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0746-2011

HiSpeed DX/I (2201000-2)

Product: HiSpeed DX/I (2201000-2)
Quantity: 102
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0747-2011

HiSpeed DX/I (2249696)

Product: HiSpeed DX/I (2249696)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0768-2011

Hi Speed DX/I (2249696-2)

Product: Hi Speed DX/I (2249696-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0770-2011

HiSpeed FX/I (2200997 with Gantry mo…

Product: HiSpeed FX/I (2200997 with Gantry mo. #2200997)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0771-2011

HiSpeed FX/I (2200997 with Gantry mo…

Product: HiSpeed FX/I (2200997 with Gantry mo. #2201000)
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0772-2011

HiSpeed FX/I (2200997 with Gantry mo…

Product: HiSpeed FX/I (2200997 with Gantry mo. #2200997-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0773-2011

HiSpeed FX/I (2200997 with Gantry mo…

Product: HiSpeed FX/I (2200997 with Gantry mo. #2201000-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0774-2011

HiSpeed FX/I (2200997 with Gantry mo…

Product: HiSpeed FX/I (2200997 with Gantry mo. #2249696)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0775-2011

HiSpeed FX/I (2200997 with Gantry mo…

Product: HiSpeed FX/I (2200997 with Gantry mo. #2249696-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0776-2011

HiSpeed FX/I (2200997-2 with Gantry mo…

Product: HiSpeed FX/I (2200997-2 with Gantry mo. #2200997)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0777-2011

HiSpeed FX/I (2200997-2 with Gantry mo…

Product: HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0778-2011

HiSpeed FX/I (2200997-2 with Gantry mo…

Product: HiSpeed FX/I (2200997-2 with Gantry mo. #2201000)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0779-2011

HiSpeed FX/I (2200997-2 with Gantry mo…

Product: HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0780-2011

HiSpeed FX/I (2200997-2 with Gantry mo…

Product: HiSpeed FX/I (2200997-2 with Gantry mo. #2249696)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0781-2011

HiSpeed FX/I (2200997-2 with Gantry mo…

Product: HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0782-2011

HiSpeed FX/I (2201000-2 with Gantry mo…

Product: HiSpeed FX/I (2201000-2 with Gantry mo. #2200997)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0783-2011

HiSpeed FX/I (2201000-2 with Gantry mo…

Product: HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0784-2011

HiSpeed FX/I (2201000-2 with Gantry mo…

Product: HiSpeed FX/I (2201000-2 with Gantry mo. #2201000)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0785-2011

HiSpeed FX/I (2201000-2 with Gantry mo…

Product: HiSpeed FX/I (2201000-2 with Gantry mo. #2201000-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0786-2011

HiSpeed FX/I (2201000-2 with Gantry mo…

Product: HiSpeed FX/I (2201000-2 with Gantry mo. #2249696)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0787-2011

HiSpeed FX/I (2201000-2 with Gantry mo…

Product: HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2)
Quantity: 102 total
Codes and lots: With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
Recall started: Feb. 1, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.
Recall number: Z-0788-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0744-2011, Z-0745-2011, Z-0746-2011, Z-0747-2011, Z-0768-2011, Z-0770-2011, Z-0771-2011, Z-0772-2011 and others. The agency record governs; check it and the company before acting.

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