FDA · Medical device recall

LightSpeed 16 Computed Tomography X-ray Systems… and 4 more products

Feb. 7, 2011

Date posted by the FDA: Feb. 7, 2011
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: Although the system x-ray output is accurate for the technique factors given, and the dose display is also accurate, certain CTDI adjustment factors used for the manual calculation from the Technical Reference Manual (TRM) are incorrect. CTDI100 Aperture Adjustment Factors for 4x0.625 mode contain incorrect values. This issue may lead to inaccurate CTDI manual calculation. The results of the diffe
Distribution pattern: Worldwide Distribution

5 products in this recall

LightSpeed 16 Computed Tomography X-ray Systems…

Product: LightSpeed 16 Computed Tomography X-ray Systems; LightSpeed 16 Computed Tomography X-ray Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications
Quantity: 1450 units total in US
Codes and lots: Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.
Recall started: Oct. 27, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.
Recall number: Z-0942-2011

GE Discovery ST (16 Slice) System…

Product: GE Discovery ST (16 Slice) System; Discovery ST (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications.
Quantity: 1450 units total in US
Codes and lots: Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.
Recall started: Oct. 27, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.
Recall number: Z-0943-2011

GE Healthcare STe (16 slice) System…

Product: GE Healthcare STe (16 slice) System; Discovery STe (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications.
Quantity: 1450 units total in US
Codes and lots: Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.
Recall started: Oct. 27, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.
Recall number: Z-0944-2011

GE Healthcare Discovery RX (16 slice) PET/CT System…

Product: GE Healthcare Discovery RX (16 slice) PET/CT System; Discovery RX (16 Slice) PET/CT Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications.
Quantity: 1450 units total in US
Codes and lots: Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.
Recall started: Oct. 27, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.
Recall number: Z-0945-2011

GE Healthcare Discovery LS (16 slice) System…

Product: GE Healthcare Discovery LS (16 slice) System; Discovery LS (16 Slice) Systems with technical Reference Manual numbers 2351785-xxx and 2390935-xxx distributed from November 2001 to August 2010. Head and whole body X-ray computed tomography applications.
Quantity: 1450 units total in US
Codes and lots: Technical Reference Manual numbers 2351785-xxx and 2390935-xxx.
Recall started: Oct. 27, 2010
Device type: System, X-Ray, Tomography, Computed
Root cause (FDA): Radiation Control for Health and Safety Act
What the company told customers: An Important Electronic Product Radiation Warning letter will be provided together with the TRM addendum informing the customers of the issue and related hazards. The letter also identified the affected product and gave instructions, which include referring to the TRM addendum, along with the product correction. This correction will be executed via a Field Modification Instruction IFMI 254281 released in November, 2010 with an estimated completion date of May, 2011. Questions or concerns should be directed to the call numbers listed or a local GE Healthcare Service Representative for countries not listed.
Recall number: Z-0946-2011

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0942-2011, Z-0943-2011, Z-0944-2011, Z-0945-2011, Z-0946-2011. The agency record governs; check it and the company before acting.

Report a mistake on this page