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Urgent Field Safety Notice PHILIPS MX 16-Slice Computed Tomography

1) Philips identified a potential issue with the Philips MX 16-slice CT system software where the orientation of images could be displayed incorrectly. 2) Users are advised to avoid using the "Gantry on the right side" orientation and restart software after errors to minimize incorrect image orientation. 3) Philips plans to issue a service pack to address this issue and other software bugs, and will schedule installations with customers.

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Mohamed Alsapagh
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457 views4 pages

Urgent Field Safety Notice PHILIPS MX 16-Slice Computed Tomography

1) Philips identified a potential issue with the Philips MX 16-slice CT system software where the orientation of images could be displayed incorrectly. 2) Users are advised to avoid using the "Gantry on the right side" orientation and restart software after errors to minimize incorrect image orientation. 3) Philips plans to issue a service pack to address this issue and other software bugs, and will schedule installations with customers.

Uploaded by

Mohamed Alsapagh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Customer Support

Philips Healthcare
(Suzhou) Co. Ltd. Field Safety Notice

-1/3- FSN MA-FCO 72800615 2014-Sep-25

URGENT Field Safety Notice-

PHILIPS MX 16-slice Computed tomography x-ray system


V1.1.4.21426 from V1.1.3_V1.1.4.21425
Dear Customer,

As part of Philips’ continuous focus on reliability and safety we continuously monitor the performance of our
products. During recent evaluations of the Philips MX 16-slice Computed tomography x-ray system, we have
identified a potential issue that may affect the performance of the equipment under certain conditions. This
letter is intended to provide you with information regarding:

• what the issue is, and under what circumstances it may occur
• the actions you can take to avoid or minimize the occurrence of the issue
• the actions planned by Philips to correct the issue

This document contains important information for the continued safe and
proper use of your equipment
Please review the following information with all members of your staff who need to be aware of the
contents of this communication. It is important to understand the implications of this communication.

Please retain a copy with the equipment Instruction for Use.

If you need any further information or support concerning this issue, please contact your local Philips
representative: Technical Support Line: 1-800-722-9377

This notice will be reported to the appropriate Regulatory Agency pursuant to applicable regulations

We apologize for any inconvenience this may cause and trust that this information is adequately addressing
any concerns you may have.

Sincerely,

Dominic Siewko
Sr. Mgr Radiation Health & Product Safety
Customer Support
Philips Healthcare
(Suzhou) Co. Ltd. Field Safety Notice

-2/3- FSN MA-FCO 72800615 2014-Sep-25

URGENT Field Safety Notice -

PHILIPS MX 16-slice Computed tomography x-ray system


V1.1.4.21426_from_V1.1.3_V1.1.4.21425
AFFECTED PRODUCTS PHILIPS MX 16-slice CT System
PROBLEM The orientation of images is displayed incorrectly. When operator chooses
DESCRIPTION gantry on the right side” from operation console, and the patient position is
HFDL, HFDR, FFDL or FFDR, the patient position picture and text is not
consistent. “L” and “R” of scan images are reversed and this is not consistent
with the patient actual position.

HAZARD INVOLVED Potential misdiagnosis or incorrect anatomy classification leading to


unnecessary treatment/procedure.

HOW TO IDENTIFY Identify affected units by the software revision: vi .1.3.1167; vi .1.4.21425;
AFFECTED PRODUCTS vi.1.4.2i424; vl.1.4.21422
How the user can identify:
For Vi .1.3 system, user can always go to “Help” page from the screen top, and
seethe software revision there. It should be 1.1.3.1167

Mx Workspace !

1.1.3.116]
10-Sep-20 10

CE
Ptuhps Mea Sy ec Nd land BV

‘Cbet.

For Vi.i.4.2i425 and later, user can navigate to “Processing”- “Service”-


System Setting” “Hospital Information” to find the software revision
-

information.
Mb’j1jInfomiatmn —I

Dm4ce eformation Hospital Information


Machine Name MX 16-slice Hospitaffiame

Serial Number Hospital Mdress

Manufacturer
IPNMS

Software Version Deice Name


11.1 jMX 16-slice
Build Number
1421425
arion Name
ICT#
Customer Support
Philips Healthcare
(Suzhou) Co. Ltd. Field Safety Notice

-3/3- FSN MA-FCO 72800615 2014-Sep-25

URGENT Field Safety Notice


-

PHILIPS MX 16-slice Computed tomography x-ray system


VI. 1.4.21426 from VI. 1.3_VI. 1.4.21425
ACTION TO BE TAKEN 1. When error is encountered, restart the Console and Application software.
BY CUSTOMER I USER 2. Avoid using Gantry on the Right side” Orientation to scan patients.
3. After the Console is started, wait for a few minutes, and then start up the
application software.

ACTIONS PLANNED BY Philips plans to install updated software in a Service Pack, the product correction
PHILIPS will be issued and will be implemented free of charge. The Service Pack will
also correct the following other issues:
. When a surview which is longer than 557mm is stopped by using
“Abort” function during the scan process, the position of scan box in
surview image is not correct.
. For dental applications, when a patient scan is taken with Gantry tilted,
and the tilt angle falls in the range from 1 to -1 degree (not including 0
degree position), the data post-processing may not operate normally and
the images may not be displayed.
. If the user stops a surview using the “Abort” function during the second
part of the scan, the positions of the scan box are not consistent.

A Philips Field Engineer will contact you shortly to schedule this correction.
FU RTH ER
IN FORMATION AND If you need any further information or support concerning this issue, please
SUPPORT contact your local Philips representative.

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