According to Charles Cassudakis, Director of CT and AMI, Field Marketing North America, Philips voluntarily suspended all CT manufacturing at its Cleveland factory based on present manufacturing quality practices and processes. To read more, visit http://www.mdbuyline.com/blog/philips-suspends-manufacturing-ct-scanners/

1. Philips Suspends Manufacturing of its CT
Scanners
March 26, 2014
by:Loretta Loncoske, BS, R.T. (R)
According to Charles Cassudakis, Director of C T and AMI, Field Marketing North America,
Philips voluntarily suspended all C T manufacturing at its Cleveland factory based on present
manufacturing quality practices and processes. Products affected include the Brilliance Big Bore,
all of the Ingenuity product line and the iCTs. Philips’ sales representatives are presently
verbally discussing this situation with its customers, but no notice or letter has come from the
company explaining the situation in full. Philips’ marketing and legal are working on a letter to
send to its customers along with a formal announcement to the public about this issue.
Once the customer letters and the accompanying announcement have been approved, M D
Buyline will work with Philips to ensure all hospital members affected are aware of the current
issues and expected resolutions. At this time, M D Buyline does not know how this affects the C
T scanners currently installed. However, we do know that no scanners will be delivered until
possibly September since Philips will need to review and redo its manufacturing processes and
practices to quality standards as required by the FDA.
According to Philips, the letter and announcement will let customers know when each product
will be released after these quality issues are resolved. M D Buyline is working with Philips
corporate and marketing and will keep consumers updated on this situation.
Companies that offer comparable C T scanners include GE, Siemens and Toshiba.
Update: March 26, 2014 at 5:00 p.m. CT
Since MD Buyline’s announcement, Philips has issued a formal statement.
Philips Healthcare Statement on Cleveland Facility
During a recent U.S. Food and Drug Administration (FDA) inspection of our Cleveland, Ohio
facility, certain issues in the general area of manufacturing process controls were brought to our
attention. The site manufactures Philips Computed Tomography and Advanced Molecular
Imaging equipment. Currently, there is no indication of product safety issues. Our customers can
remain confident in the safety of our products. Philips announced a voluntary, temporary
suspension of production at the Cleveland facility, primarily to upgrade manufacturing process

2. controls in order to resume production as soon as possible. This action was not ordered or
otherwise required by the FDA. We take this matter very seriously, and we are committed to the
highest standards of product quality and compliance with government safety regulations
everywhere in the world for medical devices, and we will continue to deliver high quality
products to our customers worldwide.
Update: March 27, 2014 at 1:30 p.m. C T
MD Buyline is advocating for our hospital members by asking their questions to Philips about
the C T suspension. After speaking with Mario Fante, Senior Manager of Public Relations, M D
Buyline is able to shed more light on this matter.
Does the temporary suspension of the CT scanners affect the installed base?
No. The temporary suspension does not affect the currently installed C T scanner base. Current
scanners will not be recalled or retrieved.
Does this affect Philips MRIs?
No. The production suspension has not affected MR, only C T scanners.
Have customers received notification from Philips yet?
Yes. Philips has issued a letter to affected customers, but M D Buyline has not yet received the
letter from Philips.
Will CT scanners be delivered this year?
At this time, we anticipate that some products will resume shipping from the Cleveland facility
in Q2 2014 with other products following in the second half of 2014,” according to Mr. Fante.
Update: April 17, 2014 at 8:30 a.m. C T
Loretta Loncoske was interviewed by DOTmed News for the article Philips suspends C T and
PET/CT production at Ohio facility.
Loretta Loncoske, a clinical analyst at M D Buyline who has been following the issue for their
hospital and health facility customers, said it is her understanding that it’s a paperwork issue and
has less to do with the machines themselves. M D Buyline is an evidence-based, clinical and
technology research firm for health care systems.
It’s more like they didn’t do their paperwork correctly — they didn’t dot all their i’s and cross all
their t’s,” she told DOTmed News.

3. Affected Philips’ products for C T include: iCT, iCT SP, Ingenuity Elite, Ingenuity Core 128,
Ingenuity Core, Ingenuity Flex, Big Bore C T, Big Bore Oncology, Brilliance 64, Brilliance 16,
IMR upgrade and iDose upgrade.
On the molecular imaging side, affected products include: BrightView XCT, BrightView X,
BrightView, Ingenuity TF PET/CT, Gemini TF 64 PET/CT, Gemini TF 16, TruFlight Select, TF
Big Bore, and Precedence.
Continue reading.
Update: April 28, 2014 at 9:00 a.m. C T
M D Buyline continues to monitor the progress and through our diligence, we have acquired the
customer letter Philips issued to its customers. See the letter.
Additionally, M D Buyline advocates for our hospital members by sharing alternative solutions
to Philips’ C T products, including:
 GE: Optima CT580 8 RT, Optima CT580 16 RT and Optima CT590 RT.
 Siemens: SOMATOM® Definition AS20 Open 20 RT. SOMATOM Definition AS Open
20, 40 and 64 systems can be configured for oncology.
 Toshiba: Aquilion™ Large Bore for oncology and radiology.
M D Buyline will continue to provide updates as we receive more information. If you have
questions, please contact us.