By

Jordan Pate
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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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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,...
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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....
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Company: CAIRE DIAGNOSTICS INC Date of Enforcement Report: 3/31/2021 Class II PRODUCT CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** – Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology. Recall Number: Z-1284-2021 REASON Erroneously...
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Company: Biomerieux Inc Date of Enforcement Report: 3/31/2021 Class II PRODUCT VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/24/2021 Class II PRODUCT Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim (Model 11061660) SOMATOM go.Open Pro (Model...
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Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report: 3/24/2021 Class II PRODUCT Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01 Recall Number: Z-1254-2021 REASON BeneVision DMS may intermittently freeze and require a...
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Company: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Date of Enforcement Report: 3/17/2021 Class II PRODUCT ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Recall Number: Z-1185-2021 REASON In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined...
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Company: Thermo Fisher Scientific Date of Enforcement Report: 3/17/2021 Class II PRODUCT Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 Recall Number: Z-1202-2021 REASON Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/10/2021 Class II PRODUCT Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161...
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Company: Medtronic Date of Enforcement Report: 3/1/2021 Class I PRODUCT HVAD Pump Implant Kits for the HeartWare HVAD System PUMP 1103 PUMP 1104 PUMP 1104JP The HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit is part of the HeartWare HVAD System, which is used to help the heart continue to pump blood to the rest...
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Company: Carl Zeiss Meditec AG Date of Enforcement Report: 2/24/2021 Class II PRODUCT IOLMaster 700 Recall Number: Z-1133-2021 REASON When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of...
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Company: Biomeme, Inc. Date of Enforcement Report: 2/10/2021 Class III PRODUCT Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler...
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Company: Topcon Medical Systems, Inc. Date of Enforcement Report: 2/10/2021 Class II PRODUCT Harmony Referral System (aka Harmony RS)/ Medical Device Data System – Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information. Recall Number: Z-0952-2021 REASON Harmony RS integrations with Topcon equipment,...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 2/10/2021 Class II PRODUCT Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx...
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Company: Community Blood Center of the Ozarks Date of Enforcement Report: 2/10/2021 Class II PRODUCT Red Blood Cells, Leukocytes Reduced Recall Number: B-0216-2021 REASON Blood products, associated with a blood bank software glitch, were distributed. RECALLING FIRM/MANUFACTURER Community Blood Center of the Ozarks on 9/25/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...
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Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 2/10/2021 Class II PRODUCT FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 – Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. Recall Number:...
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Company: Roche Molecular Systems, Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001. Recall Number: Z-0883-2021 REASON A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent...
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Company: Roche Molecular Systems, Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 Recall Number: Z-0877-2021 REASON When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is...
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Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 1/27/2021 Class II PRODUCT Synapse PACS Software Versions 5.1 and higher Recall Number: Z-0878-2021 REASON There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 1/20/2021 Class II PRODUCT All EPIQ and Affiniti Ultrasound systems. Model numbers – EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD – EPIQ 5 GMDN – 40761 100-240V 50/60 Hz, 600...
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Company: Philips Ultrasound Inc Date of Enforcement Report: 1/20/2021 Class II PRODUCT All EPIQ and Affiniti Ultrasound systems. Model numbers – EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD – EPIQ 5 GMDN – 40761 100-240V 50/60 Hz, 600...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT Atellica CH 930 Analyzer – In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11067000 – Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology...
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Company: Philips North America, LLC Date of Enforcement Report: 1/20/2021 Class II PRODUCT Emission Computed Tomography System Image Process System – Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Recall Number: Z-0852-2021 REASON A software defect that has the potential to result in image...
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Company: Medtronic Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000. Recall Number: Z-0843-2021 REASON Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 1/20/2021 Class II PRODUCT Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 – Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy. Recall Number: Z-0860-2021 REASON A710 Intellis Clinician Application has...
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Company: ICU Medical, Inc. Date of Enforcement Report: 1/20/2021 Class II PRODUCT icumedical Cogent” Hemodynamic Monitoring System – Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. Recall Number: Z-0859-2021 REASON Due to a potential software issue,...
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Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 1/13/2021 Class II PRODUCT enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN – Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate...
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Company: B Braun Medical, Inc. Date of Enforcement Report: 12/30/2020 Class II PRODUCT APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 – Product Usage: intended for intravascular administration to a patient. Recall Number: Z-0717-2021 REASON There is the potential for the compounding system to not immediately interrupt compounding and alert user to...
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Company: Baxter Healthcare Corporation Date of Enforcement Report: 12/30/2020 Class II PRODUCT Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) – Product Usage: intended to be used for the controlled administration of fluids. Recall Number: Z-0712-2021 REASON There is a potential software error during programming. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation on 11/23/2020....
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Company: Haag-Streit USA Inc Date of Enforcement Report: 12/30/2020 Class II PRODUCT Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615...
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Company: Medtronic Neuromodulation Date of Enforcement Report: 12/23/2020 Class II PRODUCT Percept PC Implantable Neurostimulator (INS) – Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy. Recall Number: Z-0612-2021 REASON A software anomaly...
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Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 12/23/2020 Class II PRODUCT RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7,...
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Company: Remote Diagnostic Technologies Ltd. Date of Enforcement Report: 12/23/2020 Class II PRODUCT Tempus LS – Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 – Product Usage: The device is intended to be used in the following environmental: – Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft). Recall Number:...
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Company: Kowa Optimed Inc Date of Enforcement Report: 12/23/2020 Class II PRODUCT Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras – Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras. Recall Number: Z-0636-2021 REASON It has been determined...
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Company: Canon Medical System, USA, INC. Date of Enforcement Report: 12/16/2020 Class II PRODUCT Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L – Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. Recall Number: Z-0549-2021 REASON A software problem has been identified which could result in the...
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Company: Shimadzu Medical Systems Date of Enforcement Report: 12/16/2020 Class II PRODUCT Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support – Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures. Recall Number: Z-0554-2021 REASON The firm has identified a problem with...
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Company: Covidien Llc Date of Enforcement Report: 12/9/2020 Class II PRODUCT Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 – Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused. Recall Number: Z-0515-2021 REASON The firm has released software update V01.05.02.16 (also known...
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