Reason: GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured dur...
Z-2258-2020June 10, 2020Waukesha, WI
Intuitive Surgical, Inc.
Class IITerminated
da Vinci SP surgical system
Reason: Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potent...
Z-2260-2020June 10, 2020Sunnyvale, CA
GE Healthcare, LLC
Class IIOngoing
System, Tomography Computed Emmission
Reason: GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured dur...
Z-2259-2020June 10, 2020Waukesha, WI
Inpeco S.A.
Class IITerminated
FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00)is...
Reason: The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Aut...
Z-2140-2020June 3, 2020Lugano, N/A
Inpeco S.A.
Class IITerminated
Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX...
Reason: The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Aut...
Z-2141-2020June 3, 2020Lugano, N/A
Inpeco S.A.
Class IITerminated
Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - P...
Reason: The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Aut...
Z-2142-2020June 3, 2020Lugano, N/A
Medtronic Inc.
Class IIOngoing
Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Reason: Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a...
Z-2106-2020June 3, 2020Northridge, CA
Immersivetouch Inc
Class IIIOngoing
ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
Reason: Observed an internal repetitive software glitch in ImmersiveView.
Z-2041-2020May 27, 2020Chicago, IL
The Binding Site Group, Ltd.
Class IITerminated
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to mea...
Reason: A software issue that may affect the analyzer's result accuracy.
Z-2071-2020May 27, 2020Birmingham, N/A
Medtronic Navigation, Inc.
Class ITerminated
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imagin...
Reason: Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System...
Z-1995-2020May 27, 2020Louisville, CO
Cuattro LLC
Class IITerminated
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Reason: There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
Z-1934-2020May 20, 2020Golden, CO
Becton, Dickinson and Company, BD Biosciences
Class IITerminated
Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic ...
Reason: Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Z-1927-2020May 13, 2020San Clemente, CA
Varian Medical Systems, Inc.
Class IITerminated
Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - P...
Reason: After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is relate...
Z-1899-2020May 13, 2020Palo Alto, CA
Philips North America, LLC
Class IITerminated
Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluoroscopic x-ray system System code: 722079
Reason: When a user acquires XperCT scan on an Azurion 2.0 system, enters the XperGuide guidance step and moves the L-arm away from the initial scan position before starting the live guida...
Z-1809-2020May 6, 2020Andover, MA
Obalon Therapeutics Inc
Class IICompleted
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and beha...
Reason: During initial set-up and/or replacement of the dispenser batteries, the touch dispenser touchscreen can inadvertently lose calibration. This issue can also occur if the touchscree...
Z-1805-2020May 6, 2020Carlsbad, CA
Viewray, Inc.
Class IITerminated
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
Reason: Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient...
Z-1803-2020May 6, 2020Mountain View, CA
ICU Medical, Inc.
Class IITerminated
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Reason: Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown,...
Z-1835-2020May 6, 2020San Clemente, CA
Elekta Inc
Class IIOngoing
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation the...
Reason: The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Z-1825-2020May 6, 2020Saint Charles, MO
Siemens Healthcare Diagnostics, Inc.
Class IITerminated
Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
Reason: Editing an assay Test Definition and switching to another assay s Test Definition screen without saving the changes using the save button on the screen, may corrupt the settings ...
Z-1797-2020May 6, 2020Tarrytown, NY
Boston Scientific Corporation
Class IICompleted
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Reason: Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) forma...
Z-1804-2020May 6, 2020Marlborough, MA
Radiometer Medical ApS
Class IITerminated
ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Reason: The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number i...
Z-1760-2020April 29, 2020Bronshoj, N/A
Beckman Coulter Inc.
Class IITerminated
Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
Reason: Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.
Z-1741-2020April 29, 2020Brea, CA
Synaptive Medical Inc
Class IITerminated
Synaptive ImageDrive Clinical
Reason: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.
Z-1759-2020April 29, 2020Toronto, N/A
Synaptive Medical Inc
Class IITerminated
ClearCanvas RIS/PACS
Reason: A software defect negatively affects the quality of images taken during diagnostic imaging (mammograms) which may result in misdiagnosis.