Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

2,985 results found for software Page 80 of 120
Hologic, Inc
Class II Terminated
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
Reason: A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results.
Z-2864-2017 August 9, 2017 San Diego, CA
Soft Computer Consultants, Inc.
Class II Terminated
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Reason: Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR...
Z-2865-2017 August 9, 2017 Clearwater, FL
Merge Healthcare, Inc.
Class II Terminated
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Ca...
Reason: When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user att...
Z-2754-2017 July 26, 2017 Hartland, WI
Medtronic Navigation, Inc.
Class II Terminated
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Reason: Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user bei...
Z-2746-2017 July 26, 2017 Louisville, CO
AGFA Healthcare Corp.
Class II Terminated
Agfa Healthcare NX 3.0.8950 Imaging Processing Software
Reason: A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong imag...
Z-2735-2017 July 26, 2017 Greenville, SC
Mako Surgical Corporation
Class II Terminated
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Reason: An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
Z-2741-2017 July 26, 2017 Davie, FL
Merge Healthcare, Inc.
Class II Terminated
The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
Reason: If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform...
Z-2707-2017 July 19, 2017 Hartland, WI
Nova Biomedical Corporation
Class II Terminated
Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 5...
Reason: Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC...
Z-2732-2017 July 19, 2017 Waltham, MA
Arjo, Inc. dba ArjoHuntleigh
Class II Terminated
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribe...
Reason: Reports of the device failure involving delivering continuous pressure to the calf garment and not deflating as intended, without triggering an alarm.
Z-2714-2017 July 19, 2017 Addison, IL
Siemens Medical Solutions USA, Inc
Class II Terminated
Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
Reason: Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examination...
Z-2688-2017 July 12, 2017 Malvern, PA
CardioTek BV
Class II Completed
CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during el...
Reason: Software bug which allows parameters to be changed unintentionally during use.
Z-2657-2017 July 12, 2017 Maastricht-Airport, N/A
Ion Beam Applications S.A.
Class II Terminated
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with local...
Reason: Software issue
Z-2684-2017 July 12, 2017 Louvain La Neuve, N/A
Ion Beam Applications S.A.
Class II Terminated
Proteus 235 and Proteus ONE proton therapy systems
Reason: Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.
Z-2672-2017 July 12, 2017 Louvain La Neuve, N/A
AGFA Healthcare Corp.
Class II Terminated
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with rep...
Reason: A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
Z-2652-2017 July 5, 2017 Greenville, SC
Merge Healthcare, Inc.
Class II Terminated
Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order e...
Reason: There are potential issues with results reporting for certain run-based tests. Under certain conditions, the wrong results could inadvertently be verified.
Z-2628-2017 July 5, 2017 Hartland, WI
Merge Healthcare, Inc.
Class II Terminated
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: Studies that have QC, PDE, or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server.
Z-2601-2017 June 28, 2017 Hartland, WI
Merge Healthcare, Inc.
Class II Terminated
Merge OrthoPACS software.
Reason: A migrated study that has annotations will display the annotations, but when a prior study is loaded that should have annotations, the second study will not display annotations.
Z-2620-2017 June 28, 2017 Hartland, WI
Merge Healthcare, Inc.
Class II Terminated
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, includi...
Reason: When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Z-2591-2017 June 21, 2017 Hartland, WI
Merge Healthcare, Inc.
Class II Terminated
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Reason: Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for vie...
Z-2590-2017 June 21, 2017 Hartland, WI
Philips Electronics North America Corporation
Class II Terminated
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105,...
Reason: Potential for early component failure.
Z-2528-2017 June 21, 2017 Andover, MA
Orthosoft, Inc. dba Zimmer CAS
Class II Terminated
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components ...
Reason: Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.
Z-2227-2017 June 14, 2017 Montreal, N/A
Nexstim PLC
Class II Ongoing
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is...
Reason: Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Z-2320-2017 June 14, 2017 Helsinki, N/A
Nexstim PLC
Class II Ongoing
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to i...
Reason: Software defect: the NBS software may accidentally generate duplicate copies of one or several files.
Z-2319-2017 June 14, 2017 Helsinki, N/A
Thoratec Corporation
Class I Terminated
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricul...
Reason: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easi...
Z-2053-2017 May 31, 2017 Pleasanton, CA
Thoratec Corporation
Class I Terminated
HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventri...
Reason: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easi...
Z-2052-2017 May 31, 2017 Pleasanton, CA