FCO - BEUDAMED

Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO 70800114.

FDA Recall

Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·October 7, 2010

EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.

FDA Enforcement

Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014

The Panorama HFO system has the Traceable Item Identification (12NC): 9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO). 9896 030 19641-SW R 2.5.3 9896 030 19861-SW R 2.6.1 9896 030 19862-SW R 2.6.1 9896 030 19863-SW R 2.6.3

FDA Recall

Terminated ·Philips Medical Systems North America Co. Phillips·Product code LNH·February 5, 2010

IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

FDA Enforcement

Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019

Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.

FDA Enforcement

Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014

Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

FDA Enforcement

Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014

Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

FDA Recall

Terminated ·Philips Ultrasound, Inc.·Product code LLZ·November 5, 2014

Ingenuity TF PET/CT 882442

FDA Recall

Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·March 28, 2018

Brilliance Big Bore Radiology 728244

FDA Recall

Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 28, 2018

Ingenuity Core128/Elite China 728324

FDA Recall

Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 28, 2018

Ingenuity Core128 728323

FDA Recall

Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 28, 2018

Philips Ingenuity Core 728321

FDA Recall

Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 28, 2018

EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1) 453561805181 (1.3.2) Diagnostic ultrasound imaging and fluid flow analysis.

FDA Recall

Terminated ·Philips Ultrasound, Inc.·Product code IYN·April 14, 2015

EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1) 453561805211 (1.3.2) Diagnostic ultrasound imaging and fluid flow analysis

FDA Recall

Terminated ·Philips Ultrasound, Inc.·Product code IYN·April 14, 2015

Leksell Gamma Knife C

FDA Recall

Terminated ·Elekta, Inc.·Product code IWB·August 1, 2006

Gyroscan NT-Intera

FDA Recall

Terminated ·Philips Medical Systems·Product code LNH·November 21, 2002

Gyroscan Intera 1.0T & 1.5T

FDA Recall

Terminated ·Philips Medical Systems·Product code LNH·November 21, 2002

EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453561772611 (1.2.1) 453561786571 (1.2.2) 453561785081 (1.3) 453561800581 (1.3.1) 453561805181 (1.3.2)

FDA Recall

Terminated ·Philips Ultrasound, Inc.·Product code IYN·April 10, 2015

Gyroscan ACS-NT with software versions R6x, R7x, R8x

FDA Recall

Terminated ·Philips Medical Systems·Product code LNH·November 21, 2002

EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251 (1.2) 453561772631 (1.2.1) 453561786591 (1.2.2) 453561785101 (1.3) 453561800601 (1.3.1) 453561805211 (1.3.2)

FDA Recall

Terminated ·Philips Ultrasound, Inc.·Product code IYN·April 10, 2015