Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Reason: A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the Electronic Medical Record (EMR).
Z-2709-2016September 7, 2016Hartland, WI
Nidek Inc
Class IITerminated
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observat...
Reason: Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA.
Z-2711-2016September 7, 2016Fremont, CA
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federati...
Reason: Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This...
Z-2704-2016September 7, 2016Tarrytown, NY
GE Healthcare It
Class IITerminated
Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the...
Reason: The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. The deletion of a slave panel will (auto slash) the corresponding test (...
Z-2671-2016September 7, 2016Barrington, IL
Novarad Corporation
Class IITerminated
NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication syste...
Reason: Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released.
Z-2659-2016August 31, 2016American Fork, UT
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data tak...
Reason: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur o...
Z-2655-2016August 31, 2016Cleveland, OH
Tecan US, Inc.
Class IITerminated
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primari...
Reason: The batteries have the potential to overheating, melt or char.
Z-2661-2016August 31, 2016Morrisville, NC
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data t...
Reason: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur o...
Z-2652-2016August 31, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data...
Reason: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur o...
Z-2658-2016August 31, 2016Cleveland, OH
Tecan US, Inc.
Class IITerminated
Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in...
Reason: The batteries have the potential to overheating, melt or char.
Z-2662-2016August 31, 2016Morrisville, NC
Siemens Healthcare Diagnostics Inc
Class IIITerminated
Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPoint 500 system is designed for professional use in a point-of care or laboratory environment. Thi...
Reason: Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States
Z-2601-2016August 31, 2016Norwood, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Reason: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, t...
Z-2624-2016August 31, 2016Malvern, PA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission...
Reason: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur o...
Z-2656-2016August 31, 2016Cleveland, OH
INNOKAS MEDICAL OY
Class IITerminated
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
Reason: A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.
Z-2604-2016August 31, 2016KEMPELE
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data ta...
Reason: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur o...
Z-2657-2016August 31, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
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 tran...
Reason: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur o...
Z-2654-2016August 31, 2016Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Reason: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, t...
Z-2625-2016August 31, 2016Malvern, PA
Tecan US, Inc.
Class IITerminated
Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain inf...
Reason: The batteries have the potential to overheating, melt or char.
Z-2666-2016August 31, 2016Morrisville, NC
Tecan US, Inc.
Class IITerminated
Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used pr...
Reason: The batteries have the potential to overheating, melt or char.
Z-2660-2016August 31, 2016Morrisville, NC
Philips Medical Systems (Cleveland) Inc
Class IITerminated
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 tra...
Reason: After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur o...
Z-2653-2016August 31, 2016Cleveland, OH
Baxter Healthcare Corp.
Class IITerminated
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located o...
Reason: In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop,...
Z-2609-2016August 31, 2016Deerfield, IL
Merge Healthcare, Inc.
Class IITerminated
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any v...
Z-2627-2016August 31, 2016Hartland, WI
Siemens Medical Solutions USA, Inc
Class IITerminated
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Reason: Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, t...
Z-2626-2016August 31, 2016Malvern, PA
Ab Sciex
Class IITerminated
AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compo...
Reason: MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Z-2526-2016August 24, 2016Framingham, MA
Merge Healthcare, Inc.
Class IITerminated
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet...
Reason: Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Stu...