Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 12/20/18 Class II PRODUCT VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Recall Number:...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report: 12/14/2018 Class II PRODUCT Xper Flex Cardio Physiomonitoring System Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 Recall Number: Z-0614-2019 REASON There are 3 issues: Under certain conditions, real time waveforms may not be accurately plotted or displayed. The...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/14/2018 Class II PRODUCT Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Recall Number: Z-0616-2019 (Vista 500, Model...Read More

Company: Tosoh Bioscience Inc Date of Enforcement Report: 12/14/2018 Class II PRODUCT AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the...Read More

Company: COVIDIEN LLC Date of Enforcement Report: 12/18/2018 Class I PRODUCT Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett” 980 Pediatric Adult Ventilator Puritan Bennett” 980 Neonatal Ventilator Puritan Bennett” 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult who...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 11/29/2018 Class II: PRODUCT Patient Monitoring System used to monitor physiologic parameter data on adult, pediatric and neonatal patients. Recall Number: Z-0519-2019 (Dash 3000), Z-0520-2019 (Dash 4000), Z-0521-2019 (Dash 5000), Z-0522-2019 (Solar 8000i), Z-0523-2019 (Solar 8000M), Z-0524-2019 (Solar 9500) REASON The patient monitors may simultaneously restart as designed if all are connected...Read More

Company: PerkinElmer Health Sciences Canada, Inc. Date of Enforcement Report: 11/28/2018 Class II: PRODUCT PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872 Recall Number: Z-0513-2019 REASON Under certain conditions...Read More

Company: Synaptive Medical Inc. Date of Enforcement Report: 11/26/2018 Class II: PRODUCT BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only /...Read More

Company: Beckman Coulter Life Sciences Date of Enforcement Report 11/20/2018 Class l: PRODUCT The FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers are used to simultaneously analyze multiple characteristics of thousands of individual cells in a relatively short period of time. These devices can be used to diagnose and monitor conditions, like blood cancers,...Read More

Company: Tosoh Bioscience Inc Date of Enforcement Report: 11/19/2018 Class II: PRODUCT Tosoh AIA-900 immunoassay Analyzer Recall Number: Z-0485-2019 REASON A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released software version 2.51 (or later)...Read More

Company: Voluntis Date of Enforcement Report: 11/16/2018 Class II: PRODUCT Insulia Diabetes Management Companion Recall Number: Z-0478-2019 REASON The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is...Read More

Company: Invivo Corporation Date of Enforcement Report: 11/14/2018 Class II: PRODUCT Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 Recall Number: Z-0462-2019 REASON The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 11/9/2018 Class II: PRODUCT Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X...Read More

Company: Medtronic Inc. Date of Enforcement Report: 11/8/2018 Class II: PRODUCT Medtronic CareLink 2090 Programmer and Encore 29901 Programmer Recall Number: Z-0406-2019 (2090), Z-0407-2019 (29901) REASON Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download. RECALLING FIRM/MANUFACTURER Medtronic Inc.,...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 11/2/2018 Class II: PRODUCT Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources. Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sources. Recall Number: Z-0374-2019 (5.0.x), Z-0375-2019 (6.0.x) REASON...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 10/24/2018 Class II: PRODUCT Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. Recall Number: Z-0195-2019 REASON Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 10/24/2018 Class II: PRODUCT Atellica Sample Handler Prime (SMN 11069001). The Atellica” Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Recall Number: Z-0189-2019 REASON Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: Reagent Lock may...Read More

Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 10/24/2018 Class II: PRODUCT Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 Recall Number: Z-0170-2019 REASON The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The...Read More

Company: AS Software, Inc Date of Enforcement Report 10/24/2018 Class II: PRODUCT AS-OBGYN Information System version 7.824.x Recall Number: Z-0118-2019 REASON Any change made to current ultrasound machine software or hardware upgrades, adding or modifying custom fields, or adding a new Ultrasound Machine, must be tested prior to the use in production environment to ensure that...Read More

Company: GE Medical Systems, LLC Date of Enforcement Report 8/24/2018 Class II: PRODUCT GE Healthcare MRI Systems, Software Version 11.x Recall Number: Z-0110-2019 REASON The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data mismatch. RECALLING...Read More

Baxter Healthcare Corporation Date of Enforcement Report 10/24/2018 Class II: PRODUCT SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 Recall Number: Z-0107-2019 REASON If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a...Read More

Company: Agfa Healthcare NV Date of Enforcement Report 10/17/2018 Class II: PRODUCT Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as PACS Recall Number: Z-0101-2019 REASON Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the...Read More

Company: GE Healthcare Finland Oy Date of Enforcement Report 10/17/2018 Class II: PRODUCT GE Healthcare CARESCAPE Monitor B450 Recall Number: Z-0095-2019 REASON When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not...Read More

Company: Synaptive Medical, Inc. Date of Enforcement Report: 10/9/2018 Class l: PRODUCT: Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration provides detailed three-dimensional (3D) images of a patient’s brain to help surgeons safely navigate surgical tools used during brain surgery. Recall Number: Z-0470-2019 REASON: Synaptive Medical has initiated this recall due to a software defect found in the BrightMatter...Read More

“Could this be a problem with the label printing software?” – Brian Pate Company: Smiths Medical ASD Inc. Date of Enforcement Report 10/10/2018 Class III: PRODUCT First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style Recall Number: Z-0071-2019 REASON “Manufactured” and “Use By” labels are transposed incorrectly suggesting the...Read More

Company: Vision RT Ltd Date of Enforcement Report 10/10/2018 Class II: PRODUCT Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only Recall Number: Z-0065-2019 REASON RTInterface error in the event of an I/O error between the IGC PCB and the Framegrabber PCB RECALLING FIRM/MANUFACTURER Vision RT Ltd London, United Kingdom on 8/24/2018 Voluntary: Firm Initiated...Read More

Company: Johnson & Johnson Surgical Vision Inc Date of Enforcement Report 10/10/2018 Class II: PRODUCT OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Recall Number: Z-0066-2019 REASON Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on...Read More

Company: Johnson & Johnson Surgical Vision Inc. Date of Enforcement Report 10/10/2018 Class lI: PRODUCT OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states “Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers:...Read More

Company: Oridion Medical 1987 Ltd. Date of Enforcement Report 10/10/2018 Class II: PRODUCT Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 – 3.2, Product #: CS08651, CS08651-01, CS08651-01, CS08651-03, CS08657, CS08657-02, CS08657-01, CS08657-03, CS08653, CS08659, CS08750, CS08751, CS78651, CS78653, CS78657, CS78659, CS08652, CS08652-01, CS08652-02, CS08652-03, CS08658, CS08658-01, CS08658-02, CS08658-03, CS08654, CS08654RA, CS08654RN, CS08660, CS08796,...Read More

Company: Vision RT LtdDate of Enforcement Report 10/10/2018 Class lI: PRODUCT Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172 Recall Number:...Read More

Company: Varian Medical SystemsDate of Enforcement Report 10/10/2018 Class lI: PRODUCT VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Recall Number: Z-0005-2019 REASON Reports have been received of...Read More

Company: Radiometer America Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or...Read More

Company: Varian Medical SystemsDate of Enforcement Report 10/3/2018 Class lI: PRODUCT TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated....Read More

Company: Boston Scientific Corporation Date of Enforcement Report 10/3/2018 Class II: PRODUCT Model 3300 LATITUDE(TM) Programming System Product Usage – The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG)....Read More

It contains all software and computer related recall excerpts for the years listed. Some of the newest recalls on the site may not be included. This compilation is provided in reverse chronological order and is useful for quick review, searches, circulation, and training purposes. A similar document is provided for warning letters. You can request...Read More

Company: Medtronic Navigation, Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 – 3.2, Product #: 9735542 Recall Number: Z-3251-2018 REASON Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the...Read More

Company: Swissray Date of Enforcement Report 10/3/2018 Class lI: PRODUCT ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging. Serial Numbers within U.S.A commerce – 1302002, 1302003, 1302005, 1302009, 1302011, 1402001, 1402002, 1402006, 1402007, 1402008, 1402009, 1402011, 1402012, 1402015, 1502001, 1502002, 1502004, 1502005, 1502006, 1502007, 1602001, 1602002, 1602003, 1602005,...Read More

Company: Tosoh Bioscience Inc.Date of Enforcement Report 10/3/2018 Class lI: PRODUCT G8 Automated HPLC Analyzer – 723G8 Product Usage – In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in...Read More

Company: Stryker GmbH. Date of Enforcement Report 10/3/2018 Class II: PRODUCT Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002 Recall Number: Z-3240-2018 REASON When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2,...Read More

Company: Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report: 9/26/2018 Class II: PRODUCT 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy Recall Number: Z-3194-2018 REASON In the hemodialysis machine during the cleaning/disinfection...Read More

Company:Fresenius Medical Care Renal Therapies Group, LLC.Date of Enforcement Report 9/26/2018 Class lI: PRODUCT 2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy. Recall Number: Z-3195-2018 REASON In the hemodialysis machine during the cleaning/disinfection program, when there...Read More

Company:Fresenius Medical Care Renal Therapies Group, LLCDate of Enforcement Report 9/26/2018 Class lI: PRODUCT 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy Recall Number: Z-3194-2018 REASON In the hemodialysis machine during the cleaning/disinfection program, when...Read More

Company:Mako Surgical Corporation Date of Enforcement Report 9/26/2018 Class lI: PRODUCT Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and...Read More

Company:Mako Surgical CorporationDate of Enforcement Report 9/26/2018 Class lI: PRODUCT Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where...Read More

Company:Mobius Imaging, LLC.. Date of Enforcement Report 9/26/2018 Class II: PRODUCT AIRO Mobile CT System Model # Mobi CT-32 Recall Number: Z-2991-2018 REASON The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is...Read More

Company:Mobius Imaging, LLC..Date of Enforcement Report 9/26/2018 Class lI: PRODUCT AIRO Mobile CT System Model # Mobi CT-32 Recall Number: Z-2991-2018 REASON The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed.....Read More

Company: Hitachi Healthcare Americas Corp Informatics Division. Date of Enforcement Report 9/12/2018 Class II: PRODUCT VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018 REASON The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study....Read More

Company:Hitachi Healthcare Americas Corp Informatics Division.Date of Enforcement Report 9/12/2018 Class lI: PRODUCT VidiStar(TM) PACS & DICOM Viewer Software system. Recall Number: Z-2992-2018 REASON The secure filesystem client software used in the interface between the Vidistar PACS and an EHR system may cause intermixed images from multiple patients showing in a single study. RECALLING FIRM/MANUFACTURER...Read More

Company:Canon Medical System, USA, INC. Date of Enforcement Report 9/12/2018 Class II: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2964-2018 REASON It was found when an operator performs a radiography using the wireless flat panel detector...Read More

Company:Canon Medical System, USA, INC.Date of Enforcement Report 9/12/2018 Class lI: PRODUCT Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2964-2018 REASON It was found when an operator performs a radiography using the wireless flat panel detector (FPD),...Read More