Reid Safety Notice

page 1 of 3

Computed Tomography .SN 16-034-72800665-72800670 2cl6 Oct 13

URGENT - Field Safety Notice

Medical Device Correction

Brilliance iCT / Brilliance iCT SP / Brilliance Big Bore / Brilliance 64

Brilliance 40 / Brilliance 16 / Brilliance 6 / Brilliance 10 / Brilliance 16P
Ingenuity CT / Ingenuity Core / Ingenuity Core128

Failed Couch Tabletop Motion

Dear Customer,

Philips Healthcare has become aware of an issue with the couch tabletop not moving during CT scan, that, if it
were to re-occur, could pose a risk for patients or users. This Field Safety Notice is intended to inform you about:
• what the problem is and under what circumstances it can occur
• the actions that should be taken by the customer / user in order to prevent risks for patients or users
• the actions planned by Philips to correct the problem.

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.

Philips will release field change orders (FCO) 72800665 and 72800670 to correct the issue on the affected
systems.

If you need any further information or support concerning this issue, please contact your local Philips
representative or local Philips Healthcare office. For North America and Canada, contact the Customer Care
Solutions Center (1-800-722-9377).

This notice has been reported to the appropriate Regulatory Agency.

PRIVILEGED AND CONFIDENTIAL.

PRINTED COPES ARE UNCONTROLLED. VERIFY DOCUMENT VERSION PRIOR TO USE
(WT4)73105-03 Rev 04
Field Safety Notice
page 2 of 3

Computed Tomography FSN 16-034-72800665-72800670 2016 Oct 13

URGENT - Field Safety Notice

Medical Device Correction

Brilliance iCT / Brilliance iCT SP / Brilliance Big Bore I Brilliance 64

Brilliance 40 / Brilliance 16 / Brilliance 6 / Brilliance 10 / Brilliance 16P
Ingenuity CT / Ingenuity Core / Ingenuity core128

Failed Couch Tabletop Motion

AFFECTED PRODUCTS The CT products below manufactured from January 1, 2006 to June 30, 2014
are potentially affected:
Brilliance iCT SP / Brilliance iCT / Brilliance 64 / Brilliance 40 / Brilliance16
Brilliance 16P / Brilliance 10 / Brilliance 6 / Brilliance Big Bore Oncology
Brilliance Big Bore Radiology I Ingenuity Core / Ingenuity Core128 / Ingenuity CT

PROBLEM The patient support table top may fail to move in the horizontal direction when it
DESCRIPTION is commanded to do so during CT scans, due to a potential mechanical linkage
failure. The system cannot automatically detect this failure to abort the scan or to
alert the user. Of the 5000 CT systems potentially affected, there have been 2
occurrences of this failure mode in the past 10 years.
HAZARD INVOLVED Undesired radiation due to multiple exposures of the same anatomical region
caused by failed couch motion during CT scanning.

HOW TO IDENTIFY If you have a potentially affected product (see above for models), identify the
I AFFECTED PRODUCTS manufacture date of the system using the label located at the bottom of the rear.
Gantry base. Affected systems were manufactured from January, 2006 to
June, 2014.
Refer to the red box on the product label example below to find the system
manufacture date.
PHILIPS MEDICAL SYSTEMS (CLEVELAND):
NC. CLEVELAND, OHIO 44143 U.S.A.
CT OR?:
PHILIPS MEDICAL SYSTEMS (CLEVELAND),
INC CLEVELAND, OHIO 44143 U.S A.
MODEL: Brilliance CT Big Bore
REF: SN:
45356'7088ö51 8008
DESCRIPTION:
728243 (ONCO), 728244 (RAD)
RATING:
SEE PEW LABEL

UFACTURED: DECEMBEre 0131

153567288341
2013

PRIVILEGED AND CONFIDENTIAL,

PRINTED COPIES ARE UNCONTROLLED, VERIFY DOCUMENT VERSION PRIOR TO USE.
CNT-073105-03 Rev 04
Field Safety Notice
page 3 of 3

Computed Tomography FSN 16-034-72800665-72800670 2016 Oct 13

URGENT - Field Safety Notice

Medical Device Correction

Brilliance iCT / Brilliance iCT SP / Brilliance Big Bore I Brilliance 64

Brilliance 40/ Brilliance 16/ Brilliance 6/ Brilliance 10/ Brilliance 16P
Ingenuity CT / Ingenuity Core / Ingenuity Core128
Failed Couch Tabletop Motion

ACTION TO BE TAKEN Customer is advised to follow the warning in the Instruction for Use: ''During all
BY CUSTOMER / USER movements of the gantry and the patient table (automatic and manual), keep the
patient under continuous observation."

If the patient table is not moving when it is commanded to move during CT scan,
abort the scan by pressing the Pause button or Emergency stop actuator. Call
your local Philips representative.

ACTIONS PLANNED BY Philips Healthcare is notifying the affected users of this issue via this Field Safety
PHILIPS Notice.

Field Change Orders (FCO) will be released to correct this issue.

A Philips Field Service Engineer will contact you to schedule the FCO updates at
your site. Reference Field Change Order (FCO) 72800665 (as necessary) and
72800670.

FURTHER If you need any further information or support concerning this issue, please
INFORMATION AND contact your local Philips representative or local Philips Healthcare office. For
SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-
722-9377).

PR P,./11, E.' GE D AND C 0 N F EN1,1AL .

Cl 1....,RE.Lif9CONTROLLED VERAFY DOCUMENT VERSION PWOR To
PRINTEDC1ES
CNI-073105-03 Rev 04
Radiation Warning Letter
page 2 of 3

Computed Tomography RWL 16-034-72800665-7280067d 2016 Oct 13

AFFECTED PRODUCTS The CT products below manufactured from January 1, 2006 to June 30, 2014
are potentially affected:
Brilliance iCT SP / Brilliance iCT / Brilliance 64 / Brilliance 40 / Brilliance16
Brilliance 16P / Brilliance 10/ Brilliance 6 / Brilliance Big Bore Oncology
Brilliance Big Bore Radiology / Ingenuity Core / Ingenuity Core128 / Ingenuity CT

PROBLEM The patient support table top may fail to move in the horizontal direction when it
DESCRIPTION is commanded to do so during CT scans, due to a potential mechanical linkage
failure. The system cannot automatically detect this failure to abort the scan or to
alert the user. Of the 5000 CT systems potentially affected, there have been 2
occurrences of this failure mode in the past 10 years.
HAZARD INVOLVED Undesired radiation due to multiple exposures of the same anatomical region
caused by failed couch motion during CT scanning.
HOW TO IDENTIFY If you have a potentially affected product (see above for models), identify the
AFFECTED PRODUCTS manufacture date of the system using the label located at the bottom of the rear
Gantry base. Affected systems were manufactured from January, 2006 to
June, 2014.
Refer to the red box on the product label example below to find the system
manufacture date.
,
PHILIPS MEDICAL SYSTEMS (CLEVELAND),
INC. CLEVELAND, OHIO 44143 U,S.A.
F ACTORY:
PHILIPS MEDICAL SYSTEMS (CLEVELAND),
INC, CLEVELAND, OHIO 44143 U.S.A.
MODEL: Brilliance CT Big Bore
REF: SN:
453567088051 _8008
DESCRIPTION:
728243 (ONCO), 728244
RATING:
SEE PDU LABEL

rvilMANUFACTURED: 1 DECEMBER'453567288341
2013

ACTION TO BE TAKEN Customer is advised to follow the warning in the Instruction for Use: "During all
BY CUSTOMER / USER movements of the gantry and the patient table (automatic and manual), keep the
patient under continuous observation."

lt the patient table is not moving when it is commanded to move during CT scan,
abort the scan by pressing the Pause button or Emergency stop actuator. Call
your local Philips representative.

Philips wih, without charf3e remedy the defect to brino the product into ,phanc. one with
the pLan to be approved by the Secretary of Heath and Human Swv
Radiation Warning Letter
page 1 of 3

Computed Tomography RWL 16-034-72800665-72800670 2016 Oct 13

Important Electronic Product Radiation Warning

Brilliance iCT / Brilliance iCT SP / Brilliance Big Bore / Brilliance 64

Brilliance 40 / Brilliance 16 / Brilliance 6 / Brilliance 10 / Brilliance 16P
Ingenuity CT / Ingenuity Core / Ingenuity core128

Failed Couch Tabletop Motion

Dear Customer,

Philips Healthcare has become aware of an issue with the couch tabletop not moving during CT scan, that, if it
were to re-occur, could pose a risk for patients or users. This Radiation Warning Letter is intended to inform you
about:
• what the problem is and under what circumstances it can occur
• the actions that should be taken by the customer / user in order to prevent risks for patients or users
• the actions planned by Philips to correct the problem.

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.

Philips will release field change orders (FCO) 72800665 and 72800670 to correct the issue on the affected
systems.

If you need any further information or support concerning this issue, please contact your local Philips
representative or local Philips Healthcare office. For North Anierica and Canada, contact the Customer Care
Solutions Center (1-800-722-9377).

This notice has been reported to the appropriate Regulatory Agency.

Philips will!, thE., defect to brine piiance in accordance with

md by the Secretary of Health add Human Service
Radiation Warning Letter
page 3 of 3

Computed Tomograhy RVVL 16-034-72800665-72800670 2016 Oct 13

ACTIONS PLANNED BY Philips Healthcare is notifying the affected users"of this issue via this Radiation
PHILIPS Warning Letter.

Field Change Orders (FCO) will be released to correct this issue.

A Philips Field Service Engineer will contact you to schedule the FCO updates at
your site. Reference Field Change Order (FCO) 72800665 (as necessary) and
72800670.

FURTHER If you need any further information or support concerning this issue, please
INFORMATION AND contact your local Philips representative or local Philips Healthcare office. For
SUPPORT North America and Canada, contact the Customer Care Solutions Center (1-800-
722-9377).

Philips will. without charge, remedy the defect to ifflng the product into compliance in accordance with
the plan to be approved by the Secretary of Health and Human Services.