Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and ...
Reason: Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which ma...
Z-1209-2019May 1, 2019Lake Zurich, IL
Brainlab AG
Class IITerminated
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0....
Reason: There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam...
Z-1205-2019May 1, 2019Munich, N/A
Ortho-Clinical Diagnostics
Class IITerminated
VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, a...
Reason: One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being report...
Z-1222-2019May 1, 2019Rochester, NY
Siemens Medical Solutions USA, Inc
Class IITerminated
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTIST...
Reason: Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to...
Z-1204-2019May 1, 2019Malvern, PA
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjun...
Reason: Software Issues.
Z-1195-2019April 24, 2019Newark, DE
bioMerieux, Inc.
Class IITerminated
Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteri...
Reason: Unexpected ESBL (Extended Spectrum Beta Lactamase) phenotype had been proposed for some Escherichia coli strains in conjunction with the VITEK 2 AST-N254, AST-N330, AST-N371 (ref.4...
Z-1137-2019April 24, 2019Durham, NC
Brainlab AG
Class ITerminated
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative ima...
Reason: In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with ...
Z-1082-2019April 24, 2019Munich, N/A
Topcon Medical Systems, Inc.
Class IITerminated
IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clin...
Reason: When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thu...
Z-1138-2019April 24, 2019Oakland, NJ
Siemens Medical Solutions USA, Inc
Class IITerminated
syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT an...
Reason: There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Z-1113-2019April 17, 2019Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT an...
Reason: There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Z-1112-2019April 17, 2019Malvern, PA
Elekta Limited
Class IITerminated
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments...
Reason: Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the...
Z-1109-2019April 17, 2019Crawley, N/A
Beckman Coulter Inc.
Class IIOngoing
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: ...
Reason: When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandli...
Z-1077-2019April 10, 2019Brea, CA
Beckman Coulter Inc.
Class IIOngoing
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the DxC system and the DxI instrument is then connected to an au...
Reason: When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandli...
Z-1078-2019April 10, 2019Brea, CA
Becton Dickinson & Co.
Class IITerminated
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinica...
Reason: BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.
Z-1051-2019April 3, 2019Sparks, MD
Accelerate Diagnostics Inc
Class IITerminated
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bo...
Reason: Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Concentration (MIC) using the affected device and a resistant result by broth microdilut...
Z-1065-2019April 3, 2019Tucson, AZ
Steris Corporation
Class IITerminated
AMSCO 3000 Series Washer/Disinfector Model # 3052
Reason: The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinf...
Z-0995-2019March 20, 2019Mentor, OH
Steris Corporation
Class IITerminated
AMSCO 5000 Series Washer/Disinfector Model # 5052
Reason: The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinf...
Z-0996-2019March 20, 2019Mentor, OH
Draegar Medical Systems, Inc.
Class IIOngoing
Omega Systems These devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when ...
Reason: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose co...
Z-0975-2019March 13, 2019Andover, MA
PENTAX of America Inc
Class IITerminated
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifi...
Reason: The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the ...
Z-0970-2019March 13, 2019Redwood City, CA
Draegar Medical Systems, Inc.
Class IIOngoing
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the par...
Reason: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose co...
Z-0974-2019March 13, 2019Andover, MA
Siemens Medical Solutions USA, Inc
Class IITerminated
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Reason: A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a differ...
Z-0936-2019March 6, 2019Malvern, PA
Baxter Healthcare Corporation
Class IITerminated
Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritone...
Reason: Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Z-0850-2019February 27, 2019Deerfield, IL
Philips North America, LLC
Class IIOngoing
PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...
Z-0860-2019February 27, 2019Andover, MA
Philips North America, LLC
Class IIOngoing
PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...
Z-0859-2019February 27, 2019Andover, MA
Philips North America, LLC
Class IIOngoing
PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric patients
Reason: Philips PageWriter TC cardiograph batteries which have reached end of life may overheat, causing the case to melt and/or the device to ignite, which can cause injury to patient or ...