ClearanceBrief
510(k) K033357 ยท JAK System, X-Ray, Tomography, Computed

ACQSIM-MULTISLICE-CT, MODEL 453567042271

ApplicantPhilips Medical Systems (Cleveland), Inc., Cleveland OH, US
DecisionSubstantially Equivalent, Jan 9, 2004
ReceivedOct 20, 2003
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K033357

DateFirm and productCodeLinked 510(k)
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244
Open, Classified
JAKNone listed
Mar 28, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Radiology 728244
Terminated
JAKNone listed
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer
Terminated
JAKNone listed
Feb 8, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by compute
Terminated
JAKNone listed
Jan 3, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recon
Terminated
JAKNone listed
Jan 3, 2018Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer recons
Terminated
JAKNone listed
Feb 23, 2017Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at differen
Terminated
JAKNone listed
Feb 23, 2017Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at differe
Terminated
JAKNone listed
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transm
Terminated
JAKNone listed
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmi
Terminated
JAKNone listed
Jun 21, 2016Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Terminated
JAKNone listed
Jun 14, 2016Philips Medical Systems (Cleveland) Inc
Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of th
Terminated
JAKNone listed
Jun 14, 2016Philips Medical Systems (Cleveland) Inc
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of
Terminated
JAKNone listed
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles an
Terminated
JAKNone listed
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles a
Terminated
JAKNone listed
Dec 10, 2015Philips Medical Systems (Cleveland) Inc
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visu
Terminated
JAKNone listed
Sep 14, 2015Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Terminated
JAKNone listed
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
JAKNone listed
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated
JAKNone listed
May 22, 2015Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angl
Terminated
JAKNone listed
Jan 15, 2015Philips Medical Systems (Cleveland) Inc
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 tran
Terminated
JAKNone listed
Sep 22, 2014Philips Medical Systems (Cleveland) Inc
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Terminated
JAXNone listed
Sep 18, 2014Philips Medical Systems (Cleveland) Inc
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same a
Terminated
JAKNone listed
Jun 22, 2014Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bor
Terminated
JAKNone listed
Jun 4, 2014Philips 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)
Terminated
JAKNone listed
Apr 16, 2014Philips Medical Systems (Cleveland) Inc
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
Terminated
JAKNone listed
Jan 29, 2014Philips Medical Systems (Cleveland) Inc
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the
Terminated
JAKNone listed
Jan 21, 2014Philips Medical Systems (Cleveland) Inc
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
Terminated
JAKNone listed
Oct 17, 2013Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are
Terminated
JAKNone listed
Mar 13, 2013Philips Medical Systems (Cleveland) Inc
Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are int
Terminated
JAKNone listed
Feb 26, 2013Philips Medical Systems (Cleveland) Inc
Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
Terminated
JAKNone listed
Aug 22, 2012Philips Medical Systems (Cleveland) Inc
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components an
Terminated
JAKNone listed
Jul 19, 2012Philips Medical Systems (Cleveland) Inc
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of th
Terminated
JAKNone listed
May 30, 2012Philips Medical Systems (Cleveland) Inc
Brilliance 40 - Model #72835, and Brilliance 64 - Model #728231, and Ingenuity - Model #728326, CT Scanning Systems are subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Big
Terminated
JAKNone listed
May 30, 2012Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore - Model #728243, and - Model #728244, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT SP and Ingen
Terminated
JAKNone listed
May 30, 2012Philips Medical Systems (Cleveland) Inc
Brilliance iCT - Model #728306, and Brilliance iCT SP - Model #728311, CT Scanning System is subject to recall/correction Product Usage: The Brilliance 6, 16, 40 64, Brilliance Big Bore, iCT, iCT S
Terminated
JAKNone listed
Feb 3, 2012Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Model #728243 and #728244, Philips Medical Systems. Computed Tomography X-Ray System intended to produce of x-ray transmission data taken at different angles and planes.
Terminated
JAKNone listed
Jan 24, 2012Philips Medical Systems (Cleveland) Inc
Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and In
Terminated
JAKNone listed
Jan 17, 2012Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore CT (Computed Tomography) System, 510 (k) #K033357, Model #728243, Serial Numbers: 7006, 7154, and 7349. The recalled CT systems are equipped with Software Version 3.5 Beta 2. Pro
Terminated
JAKNone listed
Dec 1, 2011Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243, Serial Numbers: 7298, and 7060. The recalled device systems are equipped with Version 3.5 Beta 1 softwar
Terminated
JAKNone listed
May 19, 2011Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore Computed Tomography X-Ray System, Model Number: 728243. The units subject to correction are equipped with software version: 3.5.17030. Intended to produce cross-sectional imag
Terminated
JAKNone listed
Mar 16, 2011Philips Medical Systems (Cleveland) Inc
Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brillianc
Terminated
KPSNone listed
Nov 17, 2009Philips Medical Systems (Cleveland) Inc
Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems
Terminated
JAKNone listed
Nov 17, 2009Philips Medical Systems (Cleveland) Inc
Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the following affected CT/PET scanning device systems : GEMINI TF CT/PET Systems 16 Slice, GEMINI TF CT/PET System 16 Sl
Terminated
JAKNone listed
Jan 16, 2009Philips Medical Systems (Cleveland) Inc
Vertical drive brake (on patient supports). Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. The device is a vertical drive brake that controls the vertical posi
Terminated
KPSNone listed
Oct 28, 2008Philips Medical Systems (Cleveland) Inc
Respiratory Gating System which includes: Pulmonary Digital Assembly Kit and Pulmonary Toolkit Oncology Pro, Model #455011203131 and Model #455011203191.
Terminated
KPSNone listed
Dec 29, 2007Philips Medical Systems (Cleveland) Inc
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. Philips Medical Systems, Cleveland, OH 44143. (The product is a soft
Terminated
JAKNone listed
Nov 7, 2007Philips Medical Systems (Cleveland) Inc
The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The malfunctioning software application is the Tumor Localization (Tumor LOC) application.
Terminated
JAKNone listed
Sep 26, 2007Philips Medical Systems (Cleveland) Inc
Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Bri
Terminated
KPSNone listed
Mar 17, 2007Philips Medical Systems (Cleveland) Inc
Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1)
Terminated
None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.