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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR