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Company: Vyaire Medical Date of Enforcement Report: 2/26/2020 Class II PRODUCT Bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is compressed together with the oxygen by the...
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Company: Normand-Info S.A.S.U. Date of Enforcement Report: 3/11/2020 Class II PRODUCT Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems. Recall Number: Z-1430-2020 REASON A patch was released for a critical remote code execution vulnerability in remote desktop services. This vulnerability can be exploited remotely...
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March 2, 2020 Excerpts from a warning letter of interest to software professionals: 1.b. Validation of device software is inadequate and is incomplete. Specifically, your firm did not conduct or document the results of software requirement specification and software design specification in your software verification and validation report for your Class II Swaive Thermometer. The...
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Company: Philips North America, LLC Date of Enforcement Report: 3/3/2020 Class II PRODUCT Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: – 453564067151 24-Hour Configuration – 453564067161 48-Hour Configuration – 453564067171 96-Hour Configuration...
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Company: St Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report:3/3/2020 Class II PRODUCT Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with software model 3330 Recall Number: Z-1351-2020 REASON Past updates to programmers and transmitters may lead some implantable...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/3/2020 Class II PRODUCT COHERENCE Oncologist, Model Nos. 07333680 & 07351898 Recall Number: Z-1346-2020 REASON A potential safety issue arises when an offset calculation is followed by a filter operation; correcting the image alignment after this sequence will result in incorrect offset values which could...
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December 26, 2019 Excerpts from warning letter of interest to software professionals: “The inspection also revealed that your … LED light therapy devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage,...
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In the China National Medical Products Administration (NMPA) Classification Catalog, SaMD can be Class II and III; it cannot be Class I.  This means that not all SaMD will require clinical trials and may fit into clinical exemptions for SaMD in China.  According to Medical Device Clinical Trial Exemption Catalog issued on September 30, 2018, seven...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 2/26/2020 Class II PRODUCT Luminos dRF Max, model no. 10762471 – Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal,...
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Company: Philips Medical Systems Gmbh, DMC Date of Enforcement Report: 2/26/2020 Class II PRODUCT CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 – Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Recall Number: Z-1328-2020 REASON When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state,...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 2/26/2020 Class II PRODUCT ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator – product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay. Recall Number: Z-1260-2020 REASON Atellica and ADVIA hsCRP calibrator accuracy has drifted away...
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Company: Philips Respironics, Inc. Date of Enforcement Report: 2/26/2020 Class I PRODUCT Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. Recall...
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This February 2020 Standards Navigator Report content is only available to Standards Navigator subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR Standards Navigator Report provides information and tools related to standards that play a significant role in health software and software intensive medical devices. In addition to information on existing standards, SoftwareCPR Standards...
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Kicking off the new year with regulatory and standards updates.  New public courses in 2020!
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FDA is raising awareness among health care providers and facility staff that cybersecurity vulnerabilities in certain GE Healthcare Clinical Information Central Stations and Telemetry Servers may introduce risks to patients while being monitored.  Per the FDA notice: “A security firm has identified several vulnerabilities in certain GE Healthcare Clinical Information Center workstations and Telemetry Servers,...
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Company: Degania Silicone, Ltd. Date of Enforcement Report: 1/22/2020 Class II PRODUCT Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage. Recall Number: Z-0809-2020 REASON Temperature deviation did not meet release specifications. RECALLING FIRM/MANUFACTURER Degania Silicone,...
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Company: St Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report: 1/22/2020 Class II PRODUCT Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. – Product Usage:...
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Company: GE Healthcare, LLC Date of Enforcement Report: 1/22/2020 Class I PRODUCT CARESCAPE Respiratory Module E-sCO Recall Number: Z-0754-2020 CARESCAPE Respiratory Module E-sCOVX Recall Number: Z-0755-2020 CARESCAPE Respiratory Module E-sCAiO Recall Number: Z-0756-2020 CARESCAPE Respiratory Module E-sCAiOV Recall Number: Z-0757-2020 CARESCAPE Respiratory Module E-sCAiOE Recall Number: Z-0758-2020 CARESCAPE Respiratory Module E-sCAiOVE Recall Number: Z-0759-2020 Airway...
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The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tismor Health and Wellness Pty Limited, FEI 3008932054, at 19a Garema Cct, Kingsgrove, from May 20 to 24, 2019. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Because your...
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How do I know if my device or my software is a medical device? Watch this helpful video and learn about the 513(g) process as well.  SoftwareCPR can help you plan your regulatory strategy and handle your regulatory submissions.  We would be delighted to help!
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62304 Public Training Course DATES:  February 4-6, 2020 (REGISTRATION extended through January 18, 2020) COST: 3 Full Days for $2,595.00 (Registration extended through 1/18/2020) Volume Discount:  $450 off for 4 or more students from same company Register Now:  https://events.eventzilla.net/e/2020-softwarecpr-62304-and-emerging-software-standards-training-course–sunnyvale-ca-2138757731 This 62304 Public Training Course provides a clear understanding of the 62304 standard for medical device software,...
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The Institute of Electrical and Electronics Engineers (IEEE) has approved a proposal to develop a standard for safety considerations in automated vehicle (AV) decision-making.  Purportedly, the “forthcoming IEEE standard will provide a useful tool to answer the question of what it means for an AV to drive safely,” according to the lead convener.  With technology...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 1/1/2020 Class II PRODUCT RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 – Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment...
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Company: GE Healthcare, LLC Date of Enforcement Report: 1/1/2020 Class II PRODUCT ApexPro Telemetry System – Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system...
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Company: LivaNova USA Inc Date of Enforcement Report: 1/1/2020 Class I PRODUCT VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy Recall Number: Z-0561-2020 REASON Certain Model 1000 generators (SN = 100,000) have experienced unexpected device resets, which resulted in disablement of therapy. Fourteen (14) complaints have been reported....
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Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 12/25/2019 Class II PRODUCT VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of...
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Company: GE Healthcare, LLC Date of Enforcement Report: 12/25/2019 Class II PRODUCT Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571 Recall Number: Z-0114-2020 REASON Certain Aespire and Aestiva Anesthesia Systems were...
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The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced it has recalled GE’s ApexPro telemetry server after multiple reported events of monitoring equipment not providing visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring. The potential safety issues are: Patients can experience ECG arrhythmias before and after a “no telem” condition and...
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Company: Smiths Medical ASD Inc. Date of Enforcement Report: 12/16/2019 Class I PRODUCT Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs. Recall Number: Z-0610-2020 REASON There is an anomaly in...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/20/2019 Class II PRODUCT Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and...
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Company: Draegar Medical Systems, Inc. Date of Enforcement Report: 11/20/2019 Class II PRODUCT Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301 Recall Number: Z-0372-2020 REASON The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. RECALLING FIRM/MANUFACTURER Draegar...
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Company: Abiomed, Inc. Date of Enforcement Report: 11/13/2019 Class II PRODUCT lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI Recall Number: Z-0345-2020 REASON This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 11/13/2019 Class II PRODUCT Prismaflex Control Unit, software versions below 7.21 Recall Number: Z-0276-2020 REASON Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation on 10/4/2019. Voluntary: ...
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Company: Medtronic Inc. Date of Enforcement Report: 11/13/2019 Class I PRODUCT Minimed Model 500 Remote Control for use with the MiniMed 508 Insulin Pump, model number MMT-500RU. Recall Number: Z-0177-2020 REASON There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. RECALLING FIRM/MANUFACTURER Medtronic Inc. on...
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Company: Insulet Corporation Date of Enforcement Report: 11/13/2019 Class II PRODUCT Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 Recall Number: Z-0347-2020 REASON There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last...
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Company: Zimmer Biomet Date of Enforcement Report: 11/7/2019 Class I PRODUCT The ROSA Brain device is a robotic platform that assists neurosurgeons in 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 types of instruments may be attached to...
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Company: Medical Components, Inc dba MedComp Date of Enforcement Report: 11/6/2019 Class II PRODUCT C3 Wave App, v. 2.0.5 Recall Number: Z-0222-2020 REASON When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or...
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This new draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., CDER-led combination product) and the device portion has electronics and/or software that is planned to be used as a platform, that is,...
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A probe into a series of engine failures on Airbus’s smallest jet, the A220, is studying whether a software change set off unexpected vibrations that damaged fast-moving parts and forced three emergency landings. Investigators are focusing their attention on recent changes in engine software that may have caused parts that compress air inside the engine...
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Registration for our 62304 and Emerging Standards software course February 4-6, 2020, in Sunnyvale, CA is in full swing!  Onward to higher software quality – keep pressing forward!
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Company: GE Healthcare, LLC Date of Enforcement Report: 10/23/2019 Class II PRODUCT ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System – Product Usage: These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of...
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Company: Abbott Laboratories, Inc Date of Enforcement Report: 10/16/2019 Class II PRODUCT Alinity S System, Part Number 06P16-01 Recall Number: Z-0111-2020 REASON Two software issues have been identified for the Alinity S System containing software version 2.0.0: Alinity’s Probe Wash: When Alinity’s CMV IgG Qualitative assay is run as the last assay on a sample,...
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One of the first steps on the marketing pathway for a medical device is to classify your device. As technology and innovation continue to advance, determining how to classify a device can be complex and challenging. This session will provide information on interacting with FDA for device determination and an introduction to Section 513(g) Requests...
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The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Denterprise International, Inc., 100 E. Granada Blvd. Ste. 219, Ormond Beach, Florida, from May 1, 2019 to May 6, 2019. During the inspection, an FDA investigator determined that your firm is a specifications developer, manufacturer of the...
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Company: WOM World of Medicine AG Date of Enforcement Report: 10/9/2019 Class II PRODUCT Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. Recall Number: Z-2767-2019 REASON The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk....
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Company: ELITech Group B.V. Date of Enforcement Report: 10/9/2019 Class III PRODUCT Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 – Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been...
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Company: Elekta Inc Date of Enforcement Report: 10/2/2019 Class II PRODUCT Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and...
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Company: GE Healthcare, LLC Date of Enforcement Report: 10/2/2019 Class II PRODUCT Proteus XR/a (SlOK : K993090) Recall Number: Z-2449-2019 REASON Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC on 8/9/2019. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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Company: Vital Scientific N.V. Date of Enforcement Report: 10/2/2019 Class II PRODUCT V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of...
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Company: Roche Diabetes Care, Inc. Date of Enforcement Report: 10/2/2019 Class II PRODUCT Accu-Chek Connect Diabetes Management App Recall Number: Z-2753-2019 REASON Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App. RECALLING FIRM/MANUFACTURER Roche Diabetes Care, Inc. on 5/3/2019. Voluntary:  Firm Initiated recall is...
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