Company: Philips North America LLC Date of Enforcement Report: 8/25/2021 Class II PRODUCT 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades Recall Number: Z-2314-2021 REASON When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the...Read More

Company: Philips Respironics, Inc. Date of Enforcement Report: 8/25/2021 Class II PRODUCT Trilogy Evo, Product numbers: BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B Recall Number: Z-2287-2021 REASON Two software issues have been identified related to pressure increase in the device: The first...Read More

Company: Abbott Laboratories, Inc Date of Enforcement Report: 8/18/2021 Class II PRODUCT Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories. Recall Number: Z-2241-2021 REASON A design defect (hardware and software) allows liquid waste...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/18/2021 Class I PRODUCT Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 – Kaluza C Single Perpetual License C10575 – Kaluza C Single User 1-year License C10576 – Kaluza C 10 User Network License C10577 – Kaluza C 5 User Network License C10578...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/18/2021 Class I PRODUCT Dose IQ Safety Software used with Spectrum IQ Infusion Pump Recall Number: Z-2165-2021 REASON Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded onto the Spectrum...Read More

Company: Simpleware Product Group, SYNOPSYS NORTHERN EUROPE Date of Enforcement Report: 8/18/2021 Class II PRODUCT Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options. Recall Number: Z-2253-2021 REASON A issue (bug) has been identified with the interface and image software which could...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/18/2021 Class I PRODUCT Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids. Recall Number: Z-2110-2021 REASON System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System...Read More

Company: BioMerieux SA Date of Enforcement Report: 8/18/2021 Class II PRODUCT MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. Recall Number: Z-2225-2021 REASON Software anomaly – Under certain conditions, unwanted alterations to results could be applied when...Read More

The US FDA released the 2022 user fees for certain medical device submissions and establishment registration. On August 2, 2021, the FDA announced the FY2022 user fees in a Federal Register notice titled Medical Device User Fee Rates for Fiscal Year 2022. FY2022 User fees are required for the following types of medical device submissions:...Read More

Probabilistic Genotyping Used for Criminal Prosecution In a recent article published on The Markup, software that is used to match DNA in criminal prosecution has come under scrutiny.  The software implements what is known as probabilistic genotyping, a method used when analyzing data that contains a mixture of DNA from multiple people.  The software uses complex...Read More

Jonathan Zittrain and John Bowers of the Berkman Klein Center; Samuel Finlayson, Zachary Kohane, and Andrew Beam of Harvard Medical School; and Joichi Ito of the MIT Media Lab have published an article in Science highlighting potential uses of adversarial attacks on machine learning systems in the medical context.Read More

Company: Caption Health Date of Enforcement Report: 7/28/2021 Class II PRODUCT Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0) Recall Number: Z-2111-2021 REASON The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect...Read More

Company: Soft Computer Consultants, Inc. Date of Enforcement Report: 7/28/2021 Class II PRODUCT SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be used in a clinical molecular or cytogenetics laboratory or medical research laboratory setting by knowledgeable and trained users. SoftGenomics is used to record and track activities performed in...Read More

Company: Respironics California, LLC Date of Enforcement Report: 7/28/2021 Class I PRODUCT Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10. The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, chronic respiratory...Read More

One of the most important references in creating a software development lifecycle process to assure software quality is the FDA guidance document, “General Principles of Software Validation.”  This guidance document has been around for many years.  The current version, 2.0, was released in 2002.  To many in the industry, this guidance is simply referred to...Read More

The FDA released a guidance document on the non-clinical testing and clinical considerations of ‘Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation’. The document can be downloaded from the FDA website. One point of particular interest comes from the software section, where the FDA states that “We generally consider the software for...Read More

Company: C-RAD POSITIONING AB Date of Enforcement Report: 7/21/2021 Class II PRODUCT PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0 Recall Number: Z-2075-2021 REASON PC Application Software c4D not changing site upon synchronization during the setup workflow step. RECALLING FIRM/MANUFACTURER C-RAD POSITIONING AB on 8/6/2020. Voluntary: ...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 7/14/2021 Class II PRODUCT ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000 Recall Number: Z-2029-2021 REASON Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a stepped peripheral imaging...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 7/14/2021 Class II PRODUCT The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for...Read More

Company: Olympus Corporation of the Americas Date of Enforcement Report: June 30, 2021 Class II PRODUCT Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological...Read More

On June 7th, 2021, the FDA updated their database of recognized consensus standards. This update included two new items related to medical device software. These two items are IEEE standards that are relevant to all medical devices that claim interoperability with other networked entities. They are being recognized based on their scientific and technical merit...Read More

Company: Normand-Info S.A.S.U. Date of Enforcement Report: 6/16/2021 Class II PRODUCT Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. Recall Number: Z-1831-2021 REASON Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of...Read More

Company: CHANGE HEALTHCARE CANADA COMPANY Date of Enforcement Report: 6/9/2021 Class II PRODUCT Change Healthcare Enterprise Viewer – Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. Recall Number: Z-1773-2021 REASON A software defect was identified where the Image...Read More

Company: Draeger Medical, Inc. Date of Enforcement Report: 6/9/2021 Class II PRODUCT Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 – Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. Recall Number: Z-1690-2021 REASON Three separate and unrelated problems attributed to the software used in the...Read More

Company: Medtronic Date of Enforcement Report: 6/9/2021 Class II PRODUCT Multiple MiniMed 780G Insulin Pump Models Recall Number: Z-1771-2021 REASON Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 5/26/2021 Class II PRODUCT RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B including some of the Service Packs. Standalone software treatment planning system. Recall Number: Z-1597-2021 REASON For some LINAC types, merging clinical...Read More

New to medical devices and need an orientation of the creation of instructions for use (IFU)?  A good place to start may be a website prepared by Ferry Vermeulen, a director at INSTRKTIV.  In further preparation for the Medical Device Regulation (MDR) enforcement in the EU, Ferry prepared a guide on how to create IFU for...Read More

Company: Haag-Streit USA Inc. Date of Enforcement Report: 5/19/2021 Class II PRODUCT Eyesuite 9.3.1 software, LENSTAR, MODEL LS900: ac-powered slit-lamp biomicroscope. Recall Number: Z-1560-2021 REASON Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI). RECALLING FIRM/MANUFACTURER Haag-Streit USA Inc...Read More

Company: Meridian Bioscience Inc Date of Enforcement Report: 5/19/2021 Class II PRODUCT Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file. Recall Number:...Read More

The FDA’s Office of Science and Engineering Laboratories (OSEL) works to promote the innovation and development of new lifesaving medical devices. Their goal is to use the latest science to expedite the development of medical devices. The FDA would like to bring awareness to the 20 research programs that are in place for the advancement...Read More

The FDA has issued guidance to implantable medical device users, such as those with pacemakers, to take precautions when using certain consumer electronic devices. They report that recent studies have shown that certain cell phones and smart watches contain high field strength magnets, capable of switching certain implantable medical devices to a “magnet mode” where...Read More

The European Commission (EC) has released a draft regulation that expands the device categories authorized to provide instructions for use in electronic form instead of paper instructions to include certain medical devices including SaMD.  Articles 3 and 5 describe the eligible devices and conditions where this is the case, while Articles 6 and 7 detail...Read More

The Medical Device Coordination Group (MDCG) published the ‘Guidance on Standardization for Medical Devices’ (MDCG 2021-5) on April 16, 2021. Though none of the information presented is new material, it does provide a consolidated reference point perhaps most useful to those new to the industry. It is comprised of four sections and intended to explain...Read More

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Date of Enforcement Report: 5/12/2021 Class II PRODUCT CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED). Recall Number: Z-1522-2021 CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara...Read More

Company: Philips North America LLC Date of Enforcement Report: 5/5/2021 Class II PRODUCT Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices – intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring Service numbers associated with the following: FC2010: Xper Flex Cardio 2010 Rev A 453564241901 Xper Flex Cardio 2010...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 5/5/2021 Class II PRODUCT Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese...Read More

Company: Change Healthcare Canada Company Date of Enforcement Report: 5/5/2021 Class II PRODUCT Change Healthcare Enterprise Viewer Recall Number: Z-1508-2021 REASON Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. RECALLING FIRM/MANUFACTURER Change Healthcare Canada Company on 3/17/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF...Read More

Company: Datascope Corp. Date of Enforcement Report: 5/5/2021 Class III PRODUCT Cardiosave Hybrid IABP – Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65 Recall Number: Z-1506-2021 REASON There are cybersecurity...Read More

Having trouble keeping up with standards activity? You are not alone!  The pace of new and emerging standards creates a challenge for even the most organized and well staffed software and quality assurance teams.  Whether it is digital health, risk management, software process, usability, or the ever challenging cybersecurity, being aware and understanding upcoming changes...Read More

In addition to information on existing standards, the SoftwareCPR Standards Navigator subscription keeps you up to date on new standards activity and gives you expert insight into future changes to existing standards.  Draft standards are available on a limited basis to subscribers to provide input to SoftwareCPR for the purpose of developing a position or...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/28/2021 Class II PRODUCT Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording...Read More

Company: Welch Allyn Inc Mortara Date of Enforcement Report: 4/28/2021 Class II PRODUCT ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 – Product Usage: indicated for use on adult and pediatric populations. Recall Number: Z-1482-2021 REASON Devices do not meet IEC 60601-2-27 requirements as labeled. RECALLING...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 4/21/2021 Class II PRODUCT RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) Recall Number: Z-1427-2021 REASON Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat. RECALLING FIRM/MANUFACTURER RAYSEARCH...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 4/21/2021 Class II PRODUCT ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) – US, automated hematology analyzer Software Versions 6.10 and 6.11 Recall Number: Z-1386-2021 REASON Potential Sample Identification (SID) Mismatch with 14-Character Barcodes. RECALLING FIRM/MANUFACTURER Siemens Healthcare Diagnostics, Inc. on 3/5/2021. Voluntary:  Firm Initiated recall...Read More

Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 4/7/2021 Class II PRODUCT Synapse PACS – Radiological Image Processing System – Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). Recall Number: Z-1348-2021 REASON The wrong...Read More

(April 6, 2021)— Ginny Kwan Gattinger has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR®) as a Partner. Ginny is a regulatory affairs professional specializing in software-based products with over 10 years of experience in the regulated industry including medical devices, pharmaceuticals and biotechnology. Ginny has developed regulatory strategies for a variety of SiMD/SaMD and...Read More

Company: Biocare Medical, LLC Date of Enforcement Report: 4/7/2021 Class II PRODUCT BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: ” Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 Recall Number: Z-1333-2021 REASON Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction...Read More

Company: Philips North America, LLC Date of Enforcement Report: 4/7/2021 Class II PRODUCT Philips SureSigns VM4, VM6 and VM8 – Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi”gns VM8 (863066, 863068,...Read More

On a recent podcast of Quality Injection Podcast EP12, our General Manager Brian Pate spoke with Oded Assouline on the topic of US FDA Design Controls and in particular Design Input.  Some of the questions they explored were Is a concept phase needed for defining the product or device that meets the user needs. Are validation...Read More

Company: Hitachi Medical Systems America Inc Date of Enforcement Report: 3/31/2021 Class II PRODUCT Ultrasonic pulsed doppler imaging system – Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph....Read More