Company: Elekta, Inc. Date of Enforcement Report: 9/4/2019 Class II PRODUCT Monaco Radiation Treatment Planning System (RTP) System Recall Number: Z-2409-2019 REASON Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions. RECALLING FIRM/MANUFACTURER Elekta, Inc. on 8/23/2019. Voluntary: ...Read More

Company: Phadia Ab Date of Enforcement Report: 9/4/2019 Class II PRODUCT Phadia” 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results. Recall Number: Z-2397-2019 REASON Code 7-102 Liquid...Read More

Company: Spectrum Medical Ltd. Date of Enforcement Report: 9/4/2019 Class I PRODUCT Quantum Pump Console Recall Number: Z-2238-2019 REASON Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use. RECALLING FIRM/MANUFACTURER Spectrum Medical Ltd. on 5/29/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 9/4/2019 Class II PRODUCT Alinity ci -series System Control Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes...Read More

Company: Agilent Technologies, Inc. Date of Enforcement Report: 9/4/2019 Class II PRODUCT MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by...Read More

Company: Qiagen Sciences LLC Date of Enforcement Report: 8/28/2019 Class II PRODUCT QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It...Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 8/28/2019 Class II PRODUCT ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver),...Read More

Company: Radiometer America Inc Date of Enforcement Report: 8/28/2019 Class II PRODUCT ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Recall Number: Z-2320-2019 REASON Software Security; The action is being initiated because of software security vulnerabilities with the firm’s analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment. RECALLING...Read More

Company: Luminex Corporation Date of Enforcement Report: 8/28/2019 Class II PRODUCT Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017. Recall Number: Z-2292-2019 REASON An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners...Read More

Today, the German Federal Institute for Drugs and Medical Devices (BfArM) identified critical vulnerabilities in the Wind River VxWorks real-time operating system. Affected versions of VxWorks are: VxWorks 6.5 to 6.9 (End-of-Life) VxWorks 7 (SR540 and SR610) VxWorks 653 MCE 3.x (may be affected) They pointed out that VxWorks is used in many medical devices....Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/21/2019 Class II PRODUCT SOMATOM Definition AS, Model Number 8098027 – Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician...Read More

Company: Fenwal Inc Date of Enforcement Report: 8/21/2019 Class II PRODUCT VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults,...Read More

Company: Fenwal Inc Date of Enforcement Report: 8/21/2019 Class I PRODUCT VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults,...Read More

The FDA has uncovered circumstances of drug quality data and information being inaccurate, which can mask problems and failures. Patients cannot be assured of the safety and effectiveness of their medication when data has been altered. One critical way to help ensure product quality is to prevent data integrity lapses from the outset. Over the...Read More

Company: Philips North America, LLC Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Lantis 6.1 Commander, Model # 5493072 – Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Ingenuity CT, Model # 728326, computed tomography x-ray system Recall Number: Z-2186-2019 Ingenuity Core128 Model # 728323, computed tomography x-ray system Recall Number: Z-2187-2019 Ingenuity Core Model # 728321, computed tomography x-ray system Recall Number: Z-2188-2019 iCT, Model # 728306, computed...Read More

Company: Ortho Clinical Diagnostics Date of Enforcement Report: 8/14/2019 Class II PRODUCT VITROS 250 Chemistry System, clinical chemistry analyzer Recall Number: Z-2174-2019 Recall Number: Z-2175-2019 VITROS 250AT Chemistry System, clinical chemistry analyzer Recall Number: Z-2176-2019 VITROS 350 Chemistry System, clinical chemistry analyzer Recall Number: Z-2177-2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS...Read More

Company: Philips Ultrasound Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ...Read More

Company: Abbott Gmbh & Co. KG Date of Enforcement Report: 8/14/2019 Class II PRODUCT The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,”* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a...Read More

Company: Ortho Clinical Diagnostics Inc Date of Enforcement Report: 8/14/2019 Class II PRODUCT ORTHO VISION Analyzer for ID-MTS Gel Cards (ORTHO VISION), Software Version 5.12.3 and 5.12.4, Product Code: 6904577 Recall Number: B-0800-2019 ORTHO VISION Max Analyzer for ID-MTS Gel Cards (ORTHO VISION Max), Software Version 5.12.3 and 5.12.4, Product Code: 6904576 B-0801-2019 REASON Ortho...Read More

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, TALON, an S&S Technology Company, located in Houston, TX, from March 11 – 28, 2019. During the inspection, an FDA investigator determined that your firm is a medical device manufacturer of various Class I & II medical equipment,...Read More

Company: Fresenius Kabi Date of Enforcement Report: 8/12/2019 Class I PRODUCT The Volumat MC Agilia Infusion System is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood products, into a patient’s body in controlled amounts. The pump administers fluids intravenously via an infusion tubing set and is intended...Read More

Tired of Cancer, a digital health startup based in the Netherlands, announced their release of a mobile app for fighting cancer related fatigue (CRF).  The Untire App is the first of its kind and aims to improve the quality of life for cancer patients and survivors. Thirty to forty percent of cancer patients suffer from...Read More

Company: Philips Medical Systems Nederlands Date of Enforcement Report: 8/7/2019 Class II PRODUCT Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2 Recall Number: Z-1997-2019 REASON Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion’s automatic exposure control...Read More

Company: Elekta Inc Date of Enforcement Report: 8/7/2019 Class II PRODUCT Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System Recall Number: Z-2091-2019 REASON When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle,...Read More

Company: Mississippi Valley Reg Bld Ctr Date of Enforcement Report: 8/7/2019 Class II PRODUCT Red Blood Cells, Leukocytes Reduced Recall Number: B-0768-2019 Platelets Recall Number: B-0769-2019 REASON Blood products, collected during a software error with blood mixers, were distributed. RECALLING FIRM/MANUFACTURER Mississippi Valley Reg Bld Ctr on 8/7/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME...Read More

Company: Medical Intelligence Medizintechnik Gmbh Date of Enforcement Report: 7/31/2019 Class II PRODUCT IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. Recall Number: Z-2082-2019 REASON Sometimes, although the...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report: 7/31/2019 Class II PRODUCT Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Recall Number: Z-2062-2019 REASON Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 7/31/2019 Class II PRODUCT MAC VU360, Model Number 2030360-001, Electrocardiograph Recall Number: Z-2060-2019 REASON Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report...Read More

Company: Stanley Security Solutions Inc Date of Enforcement Report: 7/31/2019 Class II PRODUCT STANLEY Healthcare Arial 54315 Network Manager Recall Number: Z-1996-2019 REASON STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial¿ 54315 Serial-to-IP Network Gateway. RECALLING FIRM/MANUFACTURER Stanley Security Solutions Inc...Read More

Company: GETINGE US SALES LLC Date of Enforcement Report: 7/31/2019 Class II PRODUCT PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the...Read More

Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 7/31/2019 Class II PRODUCT Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. Recall Number: Z-2035-2019 REASON Several reports were received that patient records were printed with the correct patient demographics but containing another patient’s waveforms. RECALLING FIRM/MANUFACTURER Spacelabs Healthcare,...Read More

Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 7/31/2019 Class II PRODUCT BrightView SPECT, Model Number 882480 Recall Number: Z-2009-2019 REASON An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc. on 6/10/2019. Voluntary:  Firm Initiated...Read More

During an inspection of your firm located in Tuttlingen, Germany, on January 25, 2012, through January 27, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-powered endoscopic grasping/cutting instruments. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these...Read More

Company: Elekta, Inc. Date of Enforcement Report: 7/24/2019 Class II PRODUCT Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 7/24/2019 Class II PRODUCT Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network...Read More

Company: Canon Medical System, USA, INC. Date of Enforcement Report: 7/17/2019 Class II PRODUCT Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on...Read More

Cybersecurity issues arise when medical devices are capable of connecting to the Internet or other medical devices. Since the FDA is concerned with regulating the safety and effectiveness of medical devices, manufacturers must ensure that the computer systems of medical devices are protected against security breaches. The link below provides the FDA Fact Sheet entitled,...Read More

Company: Hamilton Medical Date of Enforcement Report: 7/12/2019 Class I PRODUCT Hamilton Medical AG Hamilton-G5 Ventilator (PN 159001) Recall Number: Z-1874-2019 REASON New software version for affected ventilators reduces the probability of the ventilator entering an ambient state, in which the inspiratory channel and expiratory valves are opened, letting the patient breathe room air unassisted....Read More

Company: Hitachi America, Ltd., Power Systems Division Date of Enforcement Report: 7/3/2019 Class II PRODUCT PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. Recall Number: Z-1892-2019 REASON There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 7/3/2019 Class II PRODUCT Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored,...Read More

Patient Engagement Advisory Committee Meeting to Discuss Cybersecurity – September 10, 2019 On September 10, 2019 the FDA will hold a meeting of the Patient Engagement Advisory Committee. The committee provides advice to the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. During the meeting the...Read More

Dialog+ haemodialysis machines with software versions 9.xx (excluding versions 9.18, 9.1A, 9.1B) – software and hardware upgrade required (MDA/2019/024) Summary Manufactured by B. Braun Avitum AG – Malfunction of the temperature sensor can result in temperature of the dialysis fluid to be more than ±1°C outside the programmed values, which can lead to inadequate treatment....Read More

Join the FDA and NITRD on July 17 for a Listening Session on Interoperability of Medical Devices On July 17, 2019, the U.S. Food and Drug Administration (FDA) and The Networking and Information Technology Research and Development Program (NITRD) will host a listening session on the interoperability of medical devices, data and platforms. During the...Read More

The FDA is warning patients and health care providers that certain Medtronic MiniMed™ insulin pumps have potential cybersecurity risks. Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential risks.Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 6/26/2019 Class II PRODUCT LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM,...Read More

Company: Monarch Medical Technologies Date of Enforcement Report: 6/26/2019 Class II PRODUCT Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10. Recall Number: Z-1786-2019 REASON Insulin dosing calculations were erroneously high. RECALLING FIRM/MANUFACTURER Monarch Medical Technologies on 5/3/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...Read More

Company: Arkray Factory USA, Inc. Date of Enforcement Report: 6/26/2019 Class II PRODUCT AUTION HYBRID AU-4050 Recall Number: Z-1850-2019 REASON This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to...Read More

May and June 2019 was a busy period for software related recalls – there were 28 recalls as you will see later in the Newsletter. As you plan your software quality assurance activities, we encourage review of published recalls and consider what steps you have in your process to prevent similar problems. Onward toward higher...Read More