Terminated

Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. The Extended Brilliance Workspace (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.

FDA Recall Z-0906-2013 · Posted 2013-03-05

Recalling FirmPhilips Medical Systems (Cleveland) Inc

Recall StatusTerminated

Product CodeJAK

Date Initiated2012-09-28

Date Terminated2013-12-26

Product Quantity2,580 units

Reason for Recall

Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2, V4.5.2 or V4.5.3, addressing a number of non-conformances.

Firm Action

Philips Healthcare sent a Urgent Medical Device Correction letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. This Field Safety notification is to inform the actions that should be taken by the customer/user to prevent risks for patient or users, and the actions planned by Philips to correct the problem. If you need further information or supplies please contact your local Philips Healthcare office. For North American and Canada contact the Customer Care Solutions Center ( 1-800 722-9377) option 5 enter site or follow the prompts.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA including the states of AL, AT, AZ, BAH, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OR, PA, PR, PR, SC, TN, TX, VA, VT, WA, WI & WV. and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Greece, Guadeloupe, Guinea, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, LAO People's Dem, Rep., Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Malta, Martinique, Mexico, Netherlands, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela & Viet Nam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961464SELECT/SPElscint, Inc. · 1996-07-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.