ClearanceBrief
Recall Z-1722-2014 ยท JAK System, X-Ray, Tomography, Computed

Philips Medical Systems (Cleveland) Inc

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)

DateJun 4, 2014 (initiated Apr 1, 2014)
StatusTerminated
ReasonA customer reported that the table top had become free floating. A Field Service Engineer (FSE) confirmed that the service latch had become disengaged.
Root causeComponent design/selection
ActionPhilips 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 loca
Quantity6, 839 units
DistributionWorldwide 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, Cyp
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K010817MX8000 V5.0 CT SYSTEM
Philips Medical Systems (Cleveland), Inc., Jun 15, 2001
K012009MX8000 IDT CT SYSTEM
Marconi Medical Systems, Inc., Sep 13, 2001
K033326PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
Philips Medical Systems, Inc., Oct 29, 2003
K033357ACQSIM-MULTISLICE-CT, MODEL 453567042271
Philips Medical Systems (Cleveland), Inc., Jan 9, 2004
K060937BRILLIANCE VOLUME
Philips Medical Systems (Cleveland), Inc., Jun 5, 2006