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Attached to this letter, we provide instructions as part of a Service Manual Addendum on how to correct
Correction
the issue. Please add this new Addendum to the Service Manual of your device(s) and train the affected
users accordingly.
Please acknowledge that you have received this letter and that you understand that an action needs to be
taken on your part to correct this issue by filling out and returning the attached "Customer Response"
form.
Contact
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at
Information
1-800-437-1171 or your local Service Representative.
Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please
contact us immediately per the contact information above.
Sincerely,
James W. Dennison
Vice President - Quality & Regulatory
GE Healthcare
Rendered PDF File Page 3 of 4
Jeff Hersh, M.D.
Chief Medical Officer
GE Healthcare
DOC1881503, Rev:1
Page 2 of 3
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