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U.S. Department of Health and Human Services

Class 2 Device Recall Extended Brilliance Workstation (EBW)

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  Class 2 Device Recall Extended Brilliance Workstation (EBW) see related information
Date Initiated by Firm October 03, 2009
Date Posted March 24, 2011
Recall Status1 Terminated 3 on September 21, 2012
Recall Number Z-1819-2011
Recall Event ID 57962
510(K)Number K012009  
Product Classification System, x-ray, tomography, computed - Product Code KPS
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).
Code Information 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.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7000
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
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