CORE

CareLink 2090 Programmer - All Serial Numbers CareLink Encore 29901/29901A Programmer - All Serial Numbers

Pacemaker programmer

Models DCS-C4-18Fr and DCS-C4-18Fr-23

Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve.

Ingenuity Flex - 728317 Ingenuity CT - 728326, 728325 Ingenuity Core - 728321 Ingenuity Core128 - 728323, 728324 Brilliance iCT - 728306 Brilliance iCT SP - 728311 Brilliance Big Bore (Oncology) - 728243 Brilliance Big Bore (Radiology) - 728244 Brilliance 16 Slice (Air) - 728246 Brilliance 16 Slice (Power) - 728240 Brilliance 40 - 728235 Brilliance 64 - 728231 IQon Spectral CT - 728332 Brilliance 6 Slice (Air) - 728256 Brilliance 10 Slice (Air) – 728251 Brilliance CT Private Practice CV config. - 728241

Scanning Systems, Computed Tomography

Running software versions: 4.1.6 ........................ NCMDR update codes: Brillianc iCT, Brilliance iCT SP

Computed Tomography

Those issues are software related. To determine whether your system is affected, you must have one of the following systems and an affected software version: Issue 1: Image Position Accuracy issue due to Image Rotation Calibration Software Error on : Brilliance 16-Slice (Air), Brilliance CT Big Bore, Ingenuity Flex Issue 2: Tracker Image Artifact issue due to Reconstruction Software Error on : Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex Issue 3: Image Artifact issue due to X-ray Measurement Firmware Error on : Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128 All Issues: affected software versions: 3.6.1, 3.6.2, 3.6.4, 3.6.5

CT scanner