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Terminated

Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)

FDA Recall Z-1722-2014 · Posted 2014-06-04

Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-04-01
Date Terminated2018-06-26
Product Quantity6, 839 units

Reason for Recall

A customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.

Firm Action

Philips Healthcare sent an Urgent Medical Device Correction letter dated April 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed If they experience a horizontal, free-floating couch motion, to contact their Field Service Engineer immediately. Customers were instructed to retain a copy of this Field Safety Notice with the equipment Instructions for USER Use (IFU). Customers with questions or needing further information were instructed to contact their local Philips representataive or local Philips Healthcare office. For North America, contact the Customer Care Solutions Center at 1-800-722-9377, Option 5. For questions regarding this recall call 440-483-3032.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution: US nationwide including PR and DC, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Cape Verde, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Greenland, Guadeloupe, Herzegovina, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, LAO People's Dem, Rep., Latvia, Lebanon, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Mozambique, Myanmar, Nahar, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam & Yemen.

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. · 2001-09-13K010817MX8000 V5.0 CT SYSTEMPhilips Medical Systems (Cleveland), Inc. · 2001-06-15

Official Source

View FDA Recall →

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

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