Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - Product Usage: This system is intended...
Reason: Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning a...
Z-1708-2020April 22, 2020Shanghai
Abbott
Class IITerminated
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, progr...
Reason: Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed...
Z-1700-2020April 22, 2020Sylmar, CA
Sysmex America, Inc.
Class IITerminated
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to t...
Reason: Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 t...
Z-1703-2020April 22, 2020Lincolnshire, IL
Siemens Medical Solutions USA, Inc
Class IITerminated
ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Z-1677-2020April 15, 2020Malvern, PA
Beckman Coulter Inc.
Class IITerminated
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identificat...
Reason: A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that...
Z-1673-2020April 15, 2020Brea, CA
Siemens Medical Solutions USA, Inc
Class IITerminated
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Z-1679-2020April 15, 2020Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Reason: Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
Z-1678-2020April 15, 2020Malvern, PA
Haemonetics Corporation
Class IITerminated
TEG Manager software versions used in conjunction with TEG 5000 are 1.1.0, 3.0.0, 4.0.0, 4.1.0 and 4.1.1. Intended: For in vitro coagulation studies
Reason: Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG...
Z-1617-2020April 8, 2020Boston, MA
Ra Medical Systems, Inc.
Class IITerminated
Pharos Excimer Laser, Model: EX-308 - Product Usage: The Pharos EX-308 Excimer Laser System is designed to treat the skin disorders psoriasis, vitiligo, atopic dermatitis, and leukoderma using phototh...
Reason: At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the fo...
Z-1631-2020April 8, 2020Carlsbad, CA
Philips North America, LLC
Class IITerminated
Expression MR400 MRI Patient Monitoring System Model Number: 866185 Software version number: 01.03.00, 01.04.00, 01.05.00, and 01.07.00 - Product Usage: The Expression Model MR400 MRI Patient Monit...
Reason: Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for p...
Z-1616-2020April 8, 2020Andover, MA
Butterfly Network, Inc.
Class IITerminated
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 ...
Reason: Distributed without an approved 510(k)
Z-1601-2020April 8, 2020Guilford, CT
Butterfly Network, Inc.
Class IITerminated
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product ...
Reason: Distributed without an approved 510(k)
Z-1600-2020April 8, 2020Guilford, CT
Physio-Control, Inc.
Class IITerminated
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a pa...
Reason: Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result...
Z-1633-2020April 8, 2020Redmond, WA
Intellijoint Surgical, Inc.
Class IITerminated
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-oper...
Reason: During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Z-1559-2020April 1, 2020Waterloo, N/A
Hill-Rom Inc.
Class IITerminated
NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade ...
Reason: There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
Z-1554-2020April 1, 2020Cary, NC
Abbott Gmbh & Co. KG
Class IITerminated
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
Reason: Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
Z-1580-2020April 1, 2020Wiesbaden, N/A
RAYSEARCH LABORATORIES AB
Class IIOngoing
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RayStation is a software system for radiation therapy and...
Reason: Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedg...
Z-1598-2020April 1, 2020Stockholm, N/A
Elekta Impac Software
Class IIOngoing
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Reason: The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Z-1597-2020April 1, 2020Sunnyvale, CA
bioMerieux, Inc.
Class IITerminated
VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testin...
Reason: The top seal of some of the pouches was compromised which can allow moisture to enter that can impact some antibiotics on the card.
Z-1534-2020April 1, 2020Durham, NC
Boston Scientific Corporation
Class IITerminated
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachyc...
Reason: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these...
Z-1512-2020March 25, 2020Saint Paul, MN
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for...
Reason: A software issue could potentially cause the stand and table movements to be blocked.
Z-1496-2020March 25, 2020Malvern, PA
Boston Scientific Corporation
Class IITerminated
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate wi...
Reason: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these...
Z-1511-2020March 25, 2020Saint Paul, MN
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated ang...
Reason: A software issue could potentially cause the stand and table movements to be blocked.
Z-1497-2020March 25, 2020Malvern, PA
Siemens Medical Solutions USA, Inc
Class IITerminated
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiogra...
Reason: A software issue could potentially cause the stand and table movements to be blocked.