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Terminated

Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: 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-0979-2015 · Posted 2015-01-15

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-12-08
Date Terminated2015-10-01
Product Quantity500 units

Reason for Recall

Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.

Firm Action

Philips sent an Urgent - Field Safety Notice letter dated December 4, 2014 to all affected customers. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will service the system to resolve the issue. For questions contact your local Philips representative or local Philips Healthcare office.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution - AR, AZ, CA, CO, FL, FL, GA, IL, IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PA, SC, TN, TX, VA, and WA. The affected product was also distributed to one government consignee. The affected product was also distributed to the following foreign countries: Canada, Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Cayman Islands, China, Czech Republic, Denmark, Ecuador, Ethiopia, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Libyan Arab Jamahiriya, Malaysia, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, United Kingdom, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060937BRILLIANCE VOLUMEPhilips Medical Systems (Cleveland), Inc. · 2006-06-05K033357ACQSIM-MULTISLICE-CT, MODEL 453567042271Philips Medical Systems (Cleveland), Inc. · 2004-01-09K033326PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEMPhilips Medical Systems, Inc. · 2003-10-29K012009MX8000 IDT CT SYSTEMMarconi Medical Systems, Inc. · 2001-09-13

Official Source

View FDA Recall →

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

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