Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 51 of 120
GE Healthcare, LLC
Class II Ongoing
Revolution EVO, Optima CT660, Optima CT680 CT Systems.
Reason: Improperly loaded software options may result in additional X -ray radiation exposure to the patient.
Z-1900-2021 July 7, 2021 Waukesha, WI
Vero Biotech, LLC
Class I Terminated
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Reason: Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
Z-1863-2021 June 30, 2021 Atlanta, GA
Pear Therapeutics, Inc.
Class II Terminated
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Reason: Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positi...
Z-1926-2021 June 30, 2021 San Francisco, CA
Pear Therapeutics, Inc.
Class II Terminated
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Reason: Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the UDS results. Positi...
Z-1925-2021 June 30, 2021 San Francisco, CA
Abbott Laboratories Inc. (St Jude Medical)
Class II Terminated
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system ...
Reason: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Z-1854-2021 June 23, 2021 Saint Paul, MN
Abbott Laboratories Inc. (St Jude Medical)
Class II Terminated
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Reason: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Z-1855-2021 June 23, 2021 Saint Paul, MN
Abbott Laboratories Inc. (St Jude Medical)
Class II Terminated
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed fo...
Reason: Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
Z-1853-2021 June 23, 2021 Saint Paul, MN
Viewray, Inc.
Class II Terminated
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurge...
Reason: Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Z-1836-2021 June 16, 2021 Mountain View, CA
Normand-Info S.A.S.U.
Class II Terminated
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Reason: Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by use...
Z-1831-2021 June 16, 2021 Arras CEDEX, N/A
Brainlab AG
Class II Terminated
ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a m...
Reason: Display of potential patient movement might be delayed to the user for high dose treatments.
Z-1846-2021 June 16, 2021 Munich, N/A
Fujifilm Medical Systems U.S.A., Inc.
Class II Terminated
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Reason: Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered t...
Z-1775-2021 June 9, 2021 Lexington, MA
Medtronic Minimed
Class II Ongoing
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020...
Reason: Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the ...
Z-1772-2021 June 9, 2021 Northridge, CA
Draeger Medical, Inc.
Class II Terminated
Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Reason: Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect ...
Z-1692-2021 June 9, 2021 Telford, PA
Draeger Medical, Inc.
Class II Terminated
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Reason: Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect ...
Z-1690-2021 June 9, 2021 Telford, PA
Medtronic Minimed
Class II Ongoing
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP ...
Reason: Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the ...
Z-1771-2021 June 9, 2021 Northridge, CA
Draeger Medical, Inc.
Class II Terminated
Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Reason: Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect ...
Z-1693-2021 June 9, 2021 Telford, PA
Draeger Medical, Inc.
Class II Terminated
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Reason: Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect ...
Z-1691-2021 June 9, 2021 Telford, PA
CHANGE HEALTHCARE CANADA COMPANY
Class II Ongoing
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
Reason: A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
Z-1773-2021 June 9, 2021 Richmond
Siemens Medical Solutions USA, Inc
Class II Terminated
Multitom RAX with software version VF10
Reason: Siemens identified two issues, In some cases, it is possible to perform an image acquisition although more than 20% of the beam does not hit the detector. This may only occur when...
Z-1685-2021 June 9, 2021 Malvern, PA
Philips North America Llc
Class II Terminated
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple ...
Reason: Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Z-1671-2021 June 2, 2021 Cambridge, MA
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system
Reason: For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually,...
Z-1597-2021 May 26, 2021 Stockholm, N/A
RAYSEARCH LABORATORIES AB
Class II Terminated
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs
Reason: When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as select...
Z-1598-2021 May 26, 2021 Stockholm, N/A
Meridian Bioscience Inc
Class II Terminated
Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control ...
Reason: Emergency Use Application (EUA) application withdrawn as false negative results reported
Z-1541-2021 May 19, 2021 Cincinnati, OH
Haag-Streit USA Inc
Class II Ongoing
Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope.
Reason: Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
Z-1560-2021 May 19, 2021 Mason, OH
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Reason: There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device tri...
Z-1522-2021 May 12, 2021 Mounds View, MN