Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall Z-0801-2014 · Posted 2014-01-21
Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2013-12-04
Date Terminated2015-07-01
Product Quantity32 units
Reason for Recall
Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.
Firm Action
On 12/4/2013 the firm sent Urgent Medical Device Corrections letters to their customers.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.