Philips Medical Systems (Cleveland) Inc: Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).

Recall number

Z-1819-2011

Recalling firm

Philips Medical Systems (Cleveland) Inc

Product

Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. The Extended Brilliance Workplace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The EBW is also provided as a component of PET/CT and SPECT/CT systems, performing the same function as indicated above (also referred to as the NM EBW).

Status

Terminated

Initiated

2009-10-03

Posted

2011-03-24

Terminated

2012-09-21

Reason

During an FDA inspection on 10/1/2010 the firm was notified by FDA that their field action they initiated in Oct 2009, constituted a recall. The firm determined that the functional analysis feature in the Comprehensive Cardiac Analysis (CCA) was displaying incorrect values on the polar fields. The calculated results for the myocardial wall thickening was incorrect in that the numbers displayed f

Root cause

Other

Action

Philips sent an URGENT - Field Safety Notice letter dated September 29, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to be aware that the numbers displayed for "Wall Thickening" actually represent a reduction in wall thickness from ES to ED. Philips will be providing a sotware update to resolve the issue. For further information or support customers were instructed to contact their local Philips representative: Customer Care Service Center in the U.S. at 1-800-722-9377, option 5: Diagnostic Imaging option 1: CT or their local Philips representative.

Quantity

2,068 units

Distribution

Worldwide Distribution - USA including the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX , UT, VA, VT, WA, WI, WV & WY and the following countries: ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELGIUM, BRAZIL, BRUSSEL, CANADA, CHILE, CHINA, COLUMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, EDUADOR, EGYPT, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LATVIA, LEBANON, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, MIRATES, UNITED KINGDOM, VENEZUELA & YEMEN.

Lot, serial or model codes

Model Numbers EBW (CT) 728260 & EBW (Portal) 728269. EBW and NM EBW software versions v2.0.5, v2.0.11. v3.0, v3.0.1, v3.0.2, v3.5, v3.5.2, v3.5.3, v3.5.4, v3.5.35, v4.0.1, v4.0.2, v4.0.3, v4.5.1 and Brilliance Workspace Portal v2.5.1.17, v2.5.1.19.

510(k) numbers

["K012009"]

PMA numbers

not on file

Product code

KPS

Firm FEI

1525965

Firm city

Cleveland

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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