Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 56 of 120
Biosense Webster (israel), Ltd.
Class II Terminated
CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides in...
Reason: Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely...
Z-2880-2020 September 2, 2020 Yoqne'Am Illit, N/A
Shanghai United Imaging Healthcare Co., Ltd.
Class II Terminated
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to ...
Reason: In affected software version, of Positron emission tomography and computed tomography system, the CT Hounsfield unit curve may not display in real time when using the bolus trackin...
Z-2819-2020 August 26, 2020 Shanghai, N/A
NeuroLogica Corporation
Class II Terminated
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for ...
Reason: There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential d...
Z-2772-2020 August 19, 2020 Danvers, MA
Smiths Medical ASD Inc.
Class I Ongoing
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump.
Reason: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Z-2735-2020 August 12, 2020 Minneapolis, MN
Siemens Medical Solutions USA, Inc
Class II Terminated
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Reason: Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collisi...
Z-2756-2020 August 12, 2020 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into ...
Reason: Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collisi...
Z-2758-2020 August 12, 2020 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Reason: Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collisi...
Z-2755-2020 August 12, 2020 Malvern, PA
Normand-Info S.A.S.U.
Class II Terminated
Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS...
Reason: Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and PLT (Platelets) are deleted in RADV. Use may lead to erroneous results.
Z-2743-2020 August 12, 2020 Arras CEDEX
Smiths Medical ASD Inc.
Class I Ongoing
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Reason: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Z-2734-2020 August 12, 2020 Minneapolis, MN
Siemens Medical Solutions USA, Inc
Class II Terminated
SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Reason: Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collisi...
Z-2757-2020 August 12, 2020 Malvern, PA
Abbott Gmbh & Co. KG
Class II Terminated
Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
Reason: Quality Control results were not properly evaluated for QC failures.
Z-2701-2020 August 5, 2020 Wiesbaden, N/A
Siemens Medical Solutions USA, Inc
Class II Terminated
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Reason: If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further ...
Z-2688-2020 July 29, 2020 Malvern, PA
Medtronic Xomed, Inc.
Class II Terminated
Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
Reason: During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the ...
Z-2673-2020 July 29, 2020 Jacksonville, FL
DiaSorin Molecular LLC
Class II Terminated
MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutan...
Reason: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Z-2549-2020 July 22, 2020 Cypress, CA
DiaSorin Molecular LLC
Class II Terminated
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patie...
Reason: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Z-2548-2020 July 22, 2020 Cypress, CA
DiaSorin Molecular LLC
Class II Terminated
MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation o...
Reason: Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Z-2547-2020 July 22, 2020 Cypress, CA
Radiometer Medical ApS
Class II Terminated
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825,...
Reason: Potential risk of patient mix-up on analyzers due to software issues.
Z-2493-2020 July 15, 2020 Bronshoj
Radiometer Medical ApS
Class II Terminated
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all ...
Reason: Potential risk of patient mix-up on analyzers due to software issues.
Z-2494-2020 July 15, 2020 Bronshoj
Vitalconnect Inc.
Class II Terminated
VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring syst...
Reason: A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was f...
Z-2537-2020 July 15, 2020 San Jose, CA
Ra Medical Systems, Inc.
Class II Terminated
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to...
Reason: A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (r...
Z-2497-2020 July 15, 2020 Carlsbad, CA
Tomtec Imaging Systems Gmbh
Class II Ongoing
TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 r...
Reason: The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements ...
Z-2496-2020 July 15, 2020 Unterschleisheim
Ortho Clinical Diagnostics
Class II Terminated
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Reason: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Z-2483-2020 July 8, 2020 Rochester, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica Data Manager software version 1.1 Siemens Material Number (SMN): 11316888 Product Usage: are cli...
Reason: Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC ...
Z-2438-2020 July 8, 2020 Tarrytown, NY
Ortho Clinical Diagnostics
Class II Terminated
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Reason: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Z-2482-2020 July 8, 2020 Rochester, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 1131...
Reason: Unexpected interface driver behavior identified (QC) Results May Be Assigned to an Incorrect Control Lot Number, and lead to the reporting of erroneous patient results if the QC fa...
Z-2437-2020 July 8, 2020 Tarrytown, NY