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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

(March 1, 2021)— Mike Russell has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a Partner. He is not new to the firm and industry, having assisted on many engagements in the last decade as an Affiliated Expert. He was also on the TIR working group that created the AAMI TIR45- 2012 Technical...Read More

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...Read More

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...Read More

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...Read More

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,...Read More

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...Read More

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...Read More

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:...Read More

Devices that do not meet the criteria for the Breakthrough Devices Program may have a new option under the Safer Technologies Program for Medical Devices (STeP). Read our previous post on the the Breakthrough Devices Program here: FDA Breakthrough Devices Program Draft Guidance. SteP is a voluntary program for certain medical devices that are “reasonably...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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,...Read More

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...Read More

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...Read More

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....Read More

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...Read More

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...Read More

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,...Read More

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:...Read More

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...Read More

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...Read More

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...Read More

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...Read More

Company: Biomeme, Inc. Date of Enforcement Report: 12/9/2020 Class II PRODUCT The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative...Read More

Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 12/2/2020 Class II PRODUCT RayStation standalone software treatment planning system, Model No. 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, 9.1, 9.2, 10.0 – Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation...Read More

Company: Mako Surgical Corporation Date of Enforcement Report: 11/25/2020 Class II PRODUCT Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 – Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001 Recall Number: Z-0461-2021 REASON Potential incorrect validation of results due to...Read More

Company: LivaNova USA Inc Date of Enforcement Report: 11/25/2020 Class II PRODUCT VNS Therapy AspireSR Generator Recall Number: Z-0462-2021 REASON Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4. RECALLING FIRM/MANUFACTURER LivaNova USA Inc...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Atellica IM 1300 Analyzer – Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 Recall Number: Z-0473-2021 REASON Test Definition scanning may reset custom settings to defaults causing falsely low or...Read More

Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report: 11/18/2020 Class II PRODUCT Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 Recall Number: Z-0439-2021 REASON The device may detect an incorrect Heater Bag volume which may lead to a ‘Supply Bag Line Blocked’ alarm during treatment. This alarm may cause the...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 11/11/2020 Class II PRODUCT ARTIS Icono Interventional Fluoroscopic X-Ray system – Product Usage: Intended Use: 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 patients. Recall Number: Z-0400-2021...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 11/11/2020 Class II PRODUCT Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application Recall Number: Z-0319-2021 REASON There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 11/4/2020 Class II PRODUCT Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 – Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall Number: Z-0306-2021 REASON There is a potential for a smudge artifact that could be suspect...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report: 11/4/2020 Class II PRODUCT Merge LIS Recall Number: Z-0289-2021 REASON A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. on 1/23/2017. Voluntary:  Firm...Read More

Company: Pentax of America Inc Date of Enforcement Report: 11/4/2020 Class II PRODUCT 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), Recall Number: Z-0292-2021 REASON There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B)....Read More

Company: Fujifilm Medical Systems U.S.A., Inc. Date of Enforcement Report: 10/28/2020 Class II PRODUCT Synapse PACS Software Version 5.6.1 – 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: Z-0282-2021 REASON FUJIFILM...Read More