The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, seco...
Reason: Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specifi...
Z-1833-2016June 15, 2016Lake Forest, IL
Siemens Healthcare Diagnostics Inc.
Class IITerminated
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an i...
Reason: Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in th...
Z-1885-2016June 8, 2016Brookfield, CT
Siemens Healthcare Diagnostics Inc.
Class IITerminated
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Device listing # D011374, All serial numbers and lots are affected. The Dimension Vista System is an ...
Reason: Discrepant patient results on Dimension Vista Intelligent Lab Systems. Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in th...
Z-1886-2016June 8, 2016Brookfield, CT
Affymetrix Inc
Class IIITerminated
CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a microarray kit, and analysis software. The CytoScan Dx Assay consists of five reagent modules, wash b...
Reason: During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
Z-1909-2016June 8, 2016Warrensville Heights, OH
Volcano Corporation
Class IITerminated
Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the q...
Reason: Volcano has become aware of an incompatibility issue between Impacted Systems and hospital network scans. In specific circumstances, an impacted System will encounter unexpected da...
Z-1813-2016June 1, 2016Rancho Cordova, CA
RAYSEARCH LABORATORIES AB
Class IITerminated
RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
Reason: A software issue with editing tools that use the left mouse button held down, for drawing in and interacting with the patient views and beams eye views. The views can become unsync...
Z-1712-2016June 1, 2016Stockholm, N/A
Ascom US, INC.
Class IITerminated
Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
Reason: Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected ...
Z-1638-2016May 18, 2016Morrisville, NC
Hamilton Medical, Inc.
Class IITerminated
Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and ...
Reason: After performing the suctioning maneuver, including disconnecting the patient, suctioning , and reconnecting the patient, the preset pattern of ventilation many not continue as exp...
Z-1624-2016May 18, 2016Reno, NV
Neusoft Medical Systems Co., Ltd.
Class IITerminated
NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
Reason: It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description...
Z-1650-2016May 18, 2016Shenyang, N/A
Covidien LLC
Class IITerminated
Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for g...
Reason: Potential of an allergic reaction in a patient with nickel sensitivity.
Z-1619-2016May 18, 2016North Haven, CT
Covidien LLC
Class IITerminated
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used fo...
Reason: Potential of an allergic reaction in a patient with nickel sensitivity.
Z-1620-2016May 18, 2016North Haven, CT
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Reason: While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the ability to control the color region of interest, the pulsed wave or continuous wave Do...
Z-1592-2016May 11, 2016Mountain View, CA
Ab Sciex
Class IITerminated
Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number:...
Reason: Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.
Z-1586-2016May 11, 2016Framingham, MA
Nuvectra
Class IITerminated
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1...
Reason: If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (...
Z-1600-2016May 11, 2016Blaine, MN
Biomerieux Inc
Class IITerminated
VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software...
Reason: Product may lead to false susceptible results of Staphylococcus spp., Enterococcus spp., and S. agalactiae to Minocycline.
Z-1596-2016May 11, 2016Hazelwood, MO
Philips and Neusoft Medical Systems Co., Ltd.
Class IITerminated
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up t...
Reason: The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the ...
Z-1573-2016May 4, 2016Shenyang, N/A
Intuitive Surgical, Inc.
Class IITerminated
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Su...
Reason: Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning...
Z-1568-2016May 4, 2016Sunnyvale, CA
Siemens Medical Solutions USA, Inc.
Class IITerminated
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultraso...
Reason: Due to a communication error between the software and V5Ms transducers rotation function, ACUSON X700 ultrasound systems at software versions 1.1.04, display an IMG_15 error messag...
Z-1572-2016May 4, 2016Mountain View, CA
Philips Visicu
Class IITerminated
eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff.
Reason: The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the...
Z-1557-2016May 4, 2016Baltimore, MD
Ortho-Clinical Diagnostics
Class IITerminated
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known a...
Reason: The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrat...
Z-1569-2016May 4, 2016Rochester, NY
Toshiba American Medical Systems Inc
Class IITerminated
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The sys...
Reason: Toshiba American Medical Systems, Inc. is recalling the TSX-035A because of a potential problem with the Aquilion Lightning CT System iStation cover falling off of the gantry.
Z-1560-2016May 4, 2016Tustin, CA
Philips Medical Systems (Cleveland) Inc
Class IITerminated
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Reason: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gam...
Z-1506-2016April 27, 2016Cleveland, OH
Philips Medical Systems (Cleveland) Inc
Class IITerminated
Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software appli...
Reason: The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90¿ or 180¿ relative to one another. However, certain gam...
Z-1504-2016April 27, 2016Cleveland, OH
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Reason: Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cau...
Z-1520-2016April 27, 2016Malvern, PA
Optovue, Inc.
Class IITerminated
iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging dev...
Reason: A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on...