By

Jordan Pate
The Medical Device Innovation Consortium (MDIC) recently partnered with the MITRE Corporation, Adam Shostack, and the FDA to host a webinar regarding the soon to be released “Playbook for Threat Modeling Medical Devices.” The playbook was created during a series of bootcamps held by the team over the past year and the webinar provided a...
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The FDA CDRH announced the guidance documents they intend to publish in FY2022. They also announced their intention to finalize, withdraw, re-open the comment period, or re-issue a revised draft guidance for 80 percent of draft guidance documents within 3 years of the close of the comment period, and within 5 years of the close...
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September 17, 2021 CMS 617922 Excerpts from a warning letter of interest to software professionals: “The United States Food and Drug Administration (FDA) conducted an inspection of your medical device operations at 200 W. Mercer Street, Suite 500, Seattle, WA 98119 from June 3, 2021 through July 15, 2021. During the inspection, an FDA Investigator...
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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...
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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...
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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...
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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...
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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...
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The virtual AAMI/FDA/BSI International Conference on Medical Devices (the ISC) will be presented from 10:30 a.m. to 3:15 p.m. (EDT), Monday-Wednesday 18-20 October 2021. As always, the ISC will be a dynamic review of recent changes and a look to what’s ahead in health tech standards and regulation, but this year each day will have...
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Company: DePuy Orthopaedics, Inc. Date of Enforcement Report: 9/8/2021 Class II PRODUCT TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578 Recall...
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Company: Elekta Inc Date of Enforcement Report: 9/8/2021 Class II PRODUCT Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 Recall Number: Z-2406-2021 REASON If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 9/8/2021 Class II PRODUCT Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis...
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Company: Philips Medical Systems Gmbh, DMC Date of Enforcement Report: 9/8/2021 Class II PRODUCT CombiDiagnost R90 Software Version R1.0 and R1.1 Recall Number: Z-2357-2021 REASON Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 9/8/2021 Class II PRODUCT Merge Hemo, Software packages 10.2, 10.3, and 10.4 Recall Number: Z-2387-2021 REASON The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 9/1/2021 Class II PRODUCT Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. Recall Number: Z-2332-2021 REASON There is a potential that the data management system may add additional cells to...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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.
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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...
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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...
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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...
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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...
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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: ...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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:...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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