Extended Brilliance Workstation (EBW) a component of the Computed Tomography X-Ray System Model Numbers EBW (CT) 728260

FDA device recall Z-1819-2011 · posted 2011-03-24 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

KPS

Quantity affected

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,

Date initiated

2009-10-03

Date posted

2011-03-24

Date terminated

2012-09-21

Location

Cleveland, OH

Related 510(k) clearances