Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 67 of 120
Neusoft Medical Systems Co., Ltd.
Class II Terminated
NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray tube a...
Reason: Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system wh...
Z-1280-2019 May 29, 2019 Shenyang, N/A
Neusoft Medical Systems Co., Ltd.
Class II Terminated
NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray system featuring a continuously rotating x-ray...
Reason: Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system wh...
Z-1281-2019 May 29, 2019 Shenyang, N/A
Philips North America, LLC
Class II Ongoing
SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Z-1324-2019 May 22, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Z-1322-2019 May 22, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Z-1320-2019 May 22, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Z-1318-2019 May 22, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Z-1319-2019 May 22, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Z-1317-2019 May 22, 2019 Andover, MA
Philips North America, LLC
Class II Ongoing
SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Z-1321-2019 May 22, 2019 Andover, MA
Abbott Gmbh & Co. KG
Class II Terminated
Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , a...
Reason: Potential performance issues in the Alinity-ci software version 2.5.1
Z-1316-2019 May 22, 2019 Wiesbaden
Philips North America, LLC
Class II Ongoing
SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Reason: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Z-1323-2019 May 22, 2019 Andover, MA
Siemens Medical Solutions USA, Inc
Class II Terminated
Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures ...
Reason: Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of im...
Z-1295-2019 May 15, 2019 Malvern, PA
Alpha Omega Engineering
Class I Terminated
Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
Reason: If cables are improperly connected, current may reach high charge density, causing tissue harm.
Z-1216-2019 May 15, 2019 Nazerat Illit, N/A
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Atellica IM 1300 Analyzer, Material Number 11066001
Reason: There were multiple issues identified in the system software which required an update.
Z-1299-2019 May 15, 2019 Tarrytown, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Atellica IM 1600 Analyzer, Material Number 11066000
Reason: There were multiple issues identified in the system software which required an update.
Z-1300-2019 May 15, 2019 Tarrytown, NY
Ortho-Clinical Diagnostics
Class II Terminated
VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of cli...
Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Z-1289-2019 May 15, 2019 Rochester, NY
Ortho-Clinical Diagnostics
Class II Terminated
VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of ...
Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Z-1291-2019 May 15, 2019 Rochester, NY
Siemens Healthcare Diagnostics, Inc.
Class II Terminated
Atellica Sample Handler Prime, Material Number 11069001
Reason: There were multiple issues identified in the system software which required an update.
Z-1301-2019 May 15, 2019 Tarrytown, NY
Ortho-Clinical Diagnostics
Class II Terminated
VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of ana...
Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Z-1290-2019 May 15, 2019 Rochester, NY
Ortho-Clinical Diagnostics
Class II Terminated
VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of an...
Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Z-1288-2019 May 15, 2019 Rochester, NY
Ortho-Clinical Diagnostics
Class II Terminated
VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of ...
Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Z-1287-2019 May 15, 2019 Rochester, NY
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmis...
Reason: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners ...
Z-1246-2019 May 8, 2019 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and proc...
Reason: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners ...
Z-1247-2019 May 8, 2019 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmi...
Reason: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners ...
Z-1244-2019 May 8, 2019 Malvern, PA
Siemens Medical Solutions USA, Inc
Class II Terminated
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray tr...
Reason: Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners ...
Z-1245-2019 May 8, 2019 Malvern, PA