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MEDICAL DEVICE CORRECTION CONFIRMATION
CUSTOMER RESPONSE REQUIRED
We request that you PLEASE COMPLETE and return this form to GE Healthcare within two (2) weeks.
Customer/Consignee Name: _____________________________________________________________
Street Address:
City/State/ZIP/Country:
Email Address:
Phone Number:
It is important that we confirm our customers have received this correction notice. Please check one of the following and complete the
requested information and send back via one of the methods below.
We acknowledge receipt and understanding of the Medical Device Correction Notice and have alerted the appropriate personnel
at our facility regarding the safety issue and instructions. We will perform the actions as requested in the attached Medical
Device Correction Notice on all potentially affected systems.
List all Device/System Serial Number(s) known (attachment can be used):__________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
We acknowledge receipt and understanding of the Medical Device Correction Notice and no longer have a system affected by this
Medical Device Correction Notice. (Please check appropriate disposition. If multiple systems or further information, attachment
can be used.)
Sold
Device/System Serial Number(s): ___________________________________________________
New Owner, if known: ____________________________________________________________
Contact Name: __________________________________________________________________
Street Address: __________________________________________________________________
City/State/Country: ______________________________________________________________
Contact (i.e. Email, Phone): _________________________________________________________
Please provide the name of the individual with responsibility for risk and compliance.
Signature:
Printed Name:
Title:
Date (DD/MM/YYYY):
1.
Scan or take photo of completed form and email to
Note: QR code can be used to email the form: click QR code, attach photo to email, click Send
2.
Take photo of completed form and send via SMS text to +1-410-972-8096
Note: QR code can be used to text the form: click QR code, attach photo to text, click Send
3.
Fax completed form to Fax Number: +1-410-630-5938
Rendered PDF File Page 4 of 4
GE REF: 32047
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Returned
Scrapped
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Please return this form using one of the following methods:
MIC.Recall@ge.com
Other: _______________
32047 – XXXX
DOC1881503, Rev:1
GE Healthcare
QR (text)
QR (email)
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