Tag

recall

Software Recall

Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 5/11/2022 Class II PRODUCT Azurion systems with software release R1.x Recall Number: Z-0886-2022 REASON In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the...
Read More
Company: DePuy Orthopaedics, Inc. Date of Enforcement Report: 5/11/2022 Class II PRODUCT VELYS Robotic-Assisted Solution Base Product No.: 451570100 Recall Number: Z-1029-2022 REASON System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause...
Read More
Company: Becton Dickinson & Co. Date of Enforcement Report: 5/11/2022 Class II PRODUCT BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10 Recall Number: Z-1018-2022 REASON When updating BD Kiestra customers to BD Synapsys version 4.10, the custom antibiotic codes set by the customer are overwritten with the BD default antibiotic codes. RECALLING...
Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 5/4/2022 Class II PRODUCT MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x “My Therapy” Patient...
Read More
Company: Varian Medical Systems Imaging Laboratory GmbH Date of Enforcement Report: 4/20/2022 Class II PRODUCT ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1 Recall Number: Z-0942-2022 REASON Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location. RECALLING...
Read More
Company: Remote Diagnostic Technologies Ltd. Date of Enforcement Report: 4/13/2022 Class II PRODUCT Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 Recall Number: Z-0861-2022 REASON Distribution of Defibrillators that are not approved or cleared for distribution US Market. RECALLING FIRM/MANUFACTURER Remote Diagnostic Technologies Ltd. on 1/28/2022. Voluntary: Firm initiated VOLUME...
Read More
Company: Diagnos Inc. Date of Enforcement Report: 4/6/2022 Class II PRODUCT CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179 Recall Number: Z-0826-2022 REASON Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version. RECALLING FIRM/MANUFACTURER Diagnos Inc....
Read More
Company: InfuTronix LLC Date of Enforcement Report: 4/6/2022 Class II PRODUCT Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP Recall Number: Z-0832-2022 REASON An unreleased Version 4 Protocol Library was installed on Nimbus PainPro (H) infusion pumps in error that may impact patient safety...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/6/2022 Class II PRODUCT Ysio system with VC10 software version, Model Number 10281013. Radiographic system Recall Number: Z-0841-2022 REASON Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for...
Read More
Company: Philips Healthcare Date of Enforcement Report: 3/30/2022 Class II PRODUCT Azurion systems with software release R2.0.x Recall Number: Z-0734-2022 REASON In the Azurion system, the user can add a new study to a patient by selecting the option “Add Study”. The Add Study dialogue box is then displayed where the Patient Type is selected...
Read More
Company: Abbott Laboratories, Inc Date of Enforcement Report: 3/23/2022 Class II PRODUCT Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and...
Read More
Company: Brainlab AG Date of Enforcement Report: 3/16/2022 Class II PRODUCT ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST. Recall Number: Z-0733-2022 REASON The yaw angle may be incorrect...
Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 3/16/2022 Class II PRODUCT RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 . Including Service Paks:...
Read More
Company: Stryker Corporation Date of Enforcement Report: 3/16/2022 Class II PRODUCT 1688 Camera Control Unit (CCU), Catalog number: 1688010000 1688 Pendulum Camera Heads Recall Number: Z-0728-2022 REASON A software defect has been identified in the 1688 Camera Control Unit (CCU) that will cause the image on the monitor to flip upside-down into an incorrect orientation....
Read More
Company: Abiomed, Inc. Date of Enforcement Report: 2/9/2022 Class I PRODUCT OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall. Recall Number: Z-0550-2022 REASON...
Read More
Company: Philips North America LLC Date of Enforcement Report: 2/9/2022 Class II PRODUCT A software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 2/9/2022 Class II PRODUCT ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B Recall Number: Z-0547-2022 REASON Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 2/2/2022 Class II PRODUCT Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 Recall Number: Z-0515-2022 REASON Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No...
Read More
Company: Konica Minolta Healthcare Americas, Inc. Date of Enforcement Report: 1/26/2022 Class II PRODUCT ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC Recall Number: Z-0500-2022 REASON lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 1/26/2022 Class II PRODUCT 1. Sensis, material # 10764561; UDI : 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 Recall Number: Z-0515-2022 REASON Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe...
Read More
Company: Ion Beam Applications S.A. Date of Enforcement Report: 1/19/2022 Class II PRODUCT Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Recall Number: Z-0466-2022 REASON Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 1/19/2022 Class II PRODUCT SOMATOM Confidence – Computed tomography systems Model: 10590100 Recall Number: Z-0472-2022 SOMATOM Definition AS-Computed tomography system Model 8098027 Recall Number: Z-0473-2022 SOMATOM Edge Plus-Computed tomography system Model 1026700 Recall Number: Z-0474-2022 SOMATOM Definition Edge -Computed tomography system Model 10590000 Recall Number:...
Read More
Company: Abbott Molecular, Inc. Date of Enforcement Report: 12/12/2021 Class II PRODUCT Alinity m System, Part No. 08N53-002 Recall Number: Z-0461-2022 REASON There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. RECALLING FIRM/MANUFACTURER Abbott Molecular, Inc. on 12/6/2021. Voluntary: Firm initiated VOLUME OF PRODUCT...
Read More
Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/12/2021 Class II PRODUCT Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000 Recall Number: Z-0449-2022 REASON (1)Software (SW) versions V1.25.1 and lower may result...
Read More
Company: Intuitive Surgical, Inc. Date of Enforcement Report: 12/5/2021 Class II PRODUCT da Vinci SP Surgical systems with the following Model Name/ Model Number/ UDI: ASSY,PSS,SP1098,P4/ 380601-44/ 00886874114605 ASSY,SSC,SP1098,P4/ 380940-44 / 00886874114735 ASSY,VSS,SP1098,P4/ 380941-44 / 00886874114742 SOFTWARE, SYSTEM EMBEDDED RLS, SP1098, B70_P4_B327 (OS4 v4.0.0 (P4_B327) / 610112-327 / N/A Recall Number: Z-0419-2022 REASON Issue was...
Read More
Company: Philips Healthcare Date of Enforcement Report: 12/1/2021 Class II PRODUCT Philips Azurion systems with software releases 2.1(L1) and 2.1(L2) Recall Number: Z-0238-2022 REASON 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging....
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 12/1/2021 Class II PRODUCT Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135 Recall Number: Z-0296-2022 Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model...
Read More
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 12/1/2021 Class II PRODUCT Medtronic CareLink SmartSync Device Manager application software (D00U005) used by Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1, DPA2D4;...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 12/1/2021 Class II PRODUCT SOMATOM Force with software syngo.CT VB20 Model #10742326 Recall Number: Z-0283-2022 SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 Recall Number: Z-0284-2022 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 Recall Number: Z-0285-2022 SOMATOM Definition Flash with software syngo.CT...
Read More
Company: Abbott Laboratories Date of Enforcement Report: 12/1/2021 Class II PRODUCT ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89 Recall Number: Z-0271-2022 ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77; Recall Number: Z-0272-2022 REASON Twelve software-related issues affecting software...
Read More
Company: Philips North America Llc Date of Enforcement Report: 11/17/2021 Class II PRODUCT Philips Azurion Interventional Fluoroscopic X-Ray System Software version: 2.1.x Model numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228. (Azurion 3 M12, Azurion 3 M15, Azurion 5 M12, Azurion 5 M20, Azurion 7 B12, Azurion 7...
Read More
Company: Baxter Healthcare Corporation Date of Enforcement Report: 11/17/2021 Class II PRODUCT Hemodialysis Delivery System, Software Version 2.x. Recall Number: Z-0215-2022 REASON If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from...
Read More
Company: FujiFilm Healthcare Americas Corporation Date of Enforcement Report: 11/10/2021 Class II PRODUCT Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3 Recall Number: Z-0189-2022 Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3 Recall Number: Z-0190-2022 Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3 Recall Number: Z-0191-2022 Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0 Recall...
Read More
Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/10/2021 Class II PRODUCT Artis zeego, Fluoroscopic X-Ray System: Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815 Recall Number: Z-0200-2022 REASON Software error,...
Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 11/10/2021 Class II PRODUCT Clinician Programmer Application (CPA) model A610 Clinician Software Application Recall Number: Z-0201-2022 REASON A software anomaly may occur with the clinician programmer application. RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation on 9/23/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 3302 DISTRIBUTION U.S. Nationwide...
Read More
Company: MEDTECH SAS Date of Enforcement Report: 11/3/2021 Class I PRODUCT ROSA One 3.1 Brain application: The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries. Recall Number: Z-0118-2022 REASON The firm has...
Read More
Company: AB SCIEX Date of Enforcement Report: 11/3/2021 Class II PRODUCT Cliquid MD (Version 3.4) software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288 Recall Number: Z-0175-2022 REASON The values of the Internal Standard (IS) concentrations are incorrectly derived when the...
Read More
Company: Xstrahl Limited Date of Enforcement Report: 11/3/2021 Class II PRODUCT Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy – 100kV Superficial X-Ray Therapy System; (2) Xstrahl 150 Electronic Brachytherapy – 150kV Superficial X-Ray Therapy System; (3) Xstrahl 200 – 225kV Superficial / Orthovoltage X-Ray Therapy System; (4) Xstrahl...
Read More
Company: Zimmer Biomet Date of Enforcement Report: 10/29/2021 Class I PRODUCT ROSA One 3.1 Brain Application: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different...
Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 10/29/2021 Class I PRODUCT ROSA One 3.1 Brain Application: The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different...
Read More
Company: Philips Ultrasound Inc Date of Enforcement Report: 10/27/2021 Class II PRODUCT EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232 Recall Number: Z-0123-2022 REASON Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary therapy/treatment. Can occur during ultrasound-guided...
Read More
Company: Canon Medical System, USA, INC. Date of Enforcement Report: 10/27/2021 Class II PRODUCT Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A Recall Number: Z-0142-2022 REASON A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 10/27/2021 Class II PRODUCT SIGNA Premier Recall Number: Z-0132-2022 SIGNA Architect Recall Number: Z-0133-2022 SIGNA Pioneer Recall Number: Z-0134-2022 Discovery MR750w 3.0T Recall Number: Z-0135-2022 Discovery MR750 3.0T Recall Number: Z-0136-2022 SIGNA Creator, SIGNA Explorer Recall Number: Z-0137-2022 SIGNA Voyager Recall Number: Z-0138-2022 SIGNA Artist Recall Number:...
Read More
Company: Draeger Medical, Inc. Date of Enforcement Report: 10/20/2021 Class II PRODUCT Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult, pediatric and neonatal patients. Catalog Number: 8416400 Recall Number: Z-0108-2022 REASON Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of...
Read More
Company: BioMerieux SA Date of Enforcement Report: 10/20/2021 Class II PRODUCT MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System Recall Number: Z-0084-2022 REASON Under certain conditions, there is a risk for a false negative result. RECALLING FIRM/MANUFACTURER BioMerieux SA on 9/2/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
Read More
Company: Elekta Inc. Date of Enforcement Report: 10/6/2021 Class II PRODUCT Elekta Monaco – Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number: Z-2563-2021 REASON Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to...
Read More
Company: Biodex Medical Systems, Inc. Date of Enforcement Report: 10/6/2021 Class II PRODUCT Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330. Recall Number: Z-2580-2021 REASON When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have...
Read More
Company: Philips Ultrasound Inc. Date of Enforcement Report: 9/29/2021 Class II PRODUCT EPIQ Diagnostic Ultrasound Systems: Software Versions: 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 – 795120, EPIQ 5C – 795205, EPIQ 5G – 795204, EPIQ 7 – 795117, EPIQ 7C – 795201, EPIQ 7G – 795200, EPIQ CVxi -795232, EPIQ CVx – 795231 Recall...
Read More
Company: Philips Ultrasound Inc. Date of Enforcement Report: 9/29/2021 Class II PRODUCT Affiniti Diagnostic Ultrasound Systems: Software Versions: 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121, Affiniti 30 795218, Affiniti 50 795208, Affiniti 50 795118, Affiniti 70 795210, Affiniti 70 795119 Recall Number: Z-2484-2021 REASON Due to a software defect that can intermittently cause the...
Read More
Company: GE Healthcare, LLC Date of Enforcement Report: 9/29/2021 Class II PRODUCT Centricity PACS-IW with Universal Viewer – Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. Recall Number: Z-2502-2021 REASON Image acquisition failures and synchronization failure with the Centricity Enterprise Archive. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC...
Read More
1 2 3 60

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.