Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 63 of 120
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Reason: There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de...
Z-0239-2020 November 6, 2019 Mounds View, MN
Mindray DS USA, Inc. dba Mindray North America
Class II Terminated
Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic param...
Reason: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identi...
Z-0235-2020 November 6, 2019 Mahwah, NJ
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Reason: There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de...
Z-0240-2020 November 6, 2019 Mounds View, MN
Mindray DS USA, Inc. dba Mindray North America
Class II Terminated
Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, inc...
Reason: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identi...
Z-0236-2020 November 6, 2019 Mahwah, NJ
Medical Components, Inc dba MedComp
Class II Terminated
C3 Wave App, v. 2.0.5
Reason: When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surfac...
Z-0222-2020 November 6, 2019 Harleysville, PA
Mindray DS USA, Inc. dba Mindray North America
Class II Terminated
Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, includin...
Reason: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identi...
Z-0237-2020 November 6, 2019 Mahwah, NJ
LABSTYLE INNOVATIONS
Class II Terminated
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Reason: The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.
Z-0260-2020 November 6, 2019 Ramat Gan
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Reason: There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de...
Z-0241-2020 November 6, 2019 Mounds View, MN
Mindray DS USA, Inc. dba Mindray North America
Class II Terminated
Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic paramete...
Reason: NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identi...
Z-0238-2020 November 6, 2019 Mahwah, NJ
ICU Medical Inc
Class II Terminated
Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Reason: A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperabl...
Z-0171-2020 October 30, 2019 Lake Forest, IL
Life Technologies Holdings Pte Ltd
Class II Terminated
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
Reason: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is dete...
Z-0185-2020 October 30, 2019 Singapore
Life Technologies Holdings Pte Ltd
Class II Terminated
Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
Reason: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is dete...
Z-0186-2020 October 30, 2019 Singapore
Brainlab AG
Class II Terminated
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE O...
Reason: The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if us...
Z-0176-2020 October 30, 2019 Munich
Life Technologies Holdings Pte Ltd
Class II Terminated
Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
Reason: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is dete...
Z-0187-2020 October 30, 2019 Singapore
Life Technologies Holdings Pte Ltd
Class II Terminated
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8...
Reason: Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is dete...
Z-0188-2020 October 30, 2019 Singapore
Siemens Medical Solutions USA, Inc
Class II Terminated
Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures
Reason: An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may become unresponsive to normal user interaction, can only take place in rare ...
Z-0160-2020 October 30, 2019 Malvern, PA
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Reason: Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below
Z-0148-2020 October 23, 2019 Tarrytown, NY
ELITech Group B.V.
Class III Terminated
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratorie...
Reason: Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
Z-2764-2019 October 9, 2019 Spankeren, N/A
Vital Scientific N.V.
Class II Ongoing
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with cert...
Reason: Instrument stopped working due to a software lockup, and no patient results are produced.
Z-2558-2019 October 2, 2019 Dieren
Smiths Medical ASD Inc.
Class II Terminated
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; ME...
Reason: Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on...
Z-2554-2019 October 2, 2019 Minneapolis, MN
Zeus Scientific, Inc.
Class II Terminated
Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).as...
Reason: Assay files used on the open Dynex DSX Instrument to process IVD ELISA samples-programming error results in well H6 being skipped for the addition of the TMB substrate. Well H6 wil...
Z-2494-2019 September 18, 2019 Branchburg, NJ
Becton Dickinson & Co.
Class II Terminated
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Reason: An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
Z-2439-2019 September 11, 2019 Sparks, MD
Becton Dickinson & Co.
Class II Terminated
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Reason: An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
Z-2438-2019 September 11, 2019 Sparks, MD
Haag-Streit USA Inc
Class II Terminated
HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equip...
Reason: software error in the central control unit of the floor stand.
Z-2484-2019 September 11, 2019 Mason, OH
Haag-Streit USA Inc
Class II Terminated
HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment...
Reason: software error in the central control unit of the floor stand.
Z-2483-2019 September 11, 2019 Mason, OH