Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
FDA Recall Z-1461-2014 · Posted 2014-04-16
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2014-03-27
Date Terminated2016-02-02
Product Quantity135
Reason for Recall
Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.
Firm Action
A Field Safety Notice was sent to all US consignees via certified mail. Market representatives will distribute the letter internationally. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution - USA including the states of CA, FL, IL, IN, KY, MD,SC, and TX.
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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