Company: Philips Medical Systems Nederland B.V. Date of Enforcement Report: 2/28/2025 Class II PRODUCT Philips IntelliSpace Cardiovascular software, Model 830089. Recall Number: Z-1252-2025 REASON: Study data is not able to be archived, copied, or exported with the cardiovascular software version. RECALLING FIRM/MANUFACTURER: Philips Medical Systems Nederland B.V. VOLUME OF PRODUCT IN COMMERCE: 139 DISTRIBUTION: US...Read More

Company: LEICA BIOSYSTEMS NUSSLOCH GMBH Date of Enforcement Report: 2/27/2025 Class II PRODUCT Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01 Recall Number: Z-1247-2025 REASON: Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue. RECALLING FIRM/MANUFACTURER: LEICA...Read More

Company: INTELERAD MEDICAL SYSTEMS INCORPORATED Date of Enforcement Report: 2/25/2025 Class II PRODUCT IntelePACS (Image Fusion Module) – InteleViewer Recall Number: Z-1208-2025 REASON: A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired...Read More

Company: BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. Date of Enforcement Report: 2/25/2025 Class II PRODUCT DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software. Recall Number: Z-1233-2025 REASON: Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates...Read More

Company: Elekta, Inc. Date of Enforcement Report: 2/11/2025 Class II PRODUCT MOSAIQ Oncology Information System Recall Number: Z-1162-2025 REASON: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. RECALLING FIRM/MANUFACTURER: Elekta, Inc. VOLUME OF PRODUCT IN COMMERCE: 64 units DISTRIBUTION: US: PA, AL, FL,...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 2/07/2025 Class II PRODUCT (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00 Recall Number: Z-0810-2025 REASON: Software issues could potentially result in: 1)...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 2/07/2025 Class II PRODUCT (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00 Recall Number: Z-1119-2025 REASON: Software issues could potentially result in: 1)...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 2/06/2025 Class II PRODUCT Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument Recall Number: Z-1115-2025 REASON: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results. RECALLING FIRM/MANUFACTURER: Beckman Coulter,...Read More

Company: Medicrea International. Date of Enforcement Report: 2/06/2025 Class II PRODUCT UNiD” Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display,...Read More

Company: Medicrea International Date of Enforcement Report: 2/06/2025 Class II PRODUCT UNiD” Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display,...Read More

Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 2/04/2025 Class I PRODUCT Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration. Recall Number: Z-1019-2025 REASON: Large Volume Pump Software, version 5.9.2 and earlier...Read More

Company: Ortho-Clinical Diagnostics, INC. Date of Enforcement Report: 1/21/2025 Class II PRODUCT Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component Recall...Read More

Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 1/07/2025 Class II PRODUCT Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data. Recall Number: Z-0810-2025 REASON: Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report: 12/27/2024 Class II PRODUCT SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B Recall Number: Z-0771-2025 REASON: Software issues were identified in application version 2.x. RECALLING FIRM/MANUFACTURER: Medtronic Neuromodulation...Read More

Company: Braemar Manufacturing, LLC Date of Enforcement Report: 12/23/2024 Class I PRODUCT Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices. Recall Number: Z-0708-2025 REASON: Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 12/20/2024 Class II PRODUCT epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood...Read More

Company: Nova Biomedical Corporation Date of Enforcement Report: 12/20/2024 Class I PRODUCT StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing Recall Number: Z-0681-2025 REASON: A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare...Read More

Company: Mint Medical GmbH Date of Enforcement Report: 12/19/2024 Class: II PRODUCT: mint Lesion, Software Versions: 3.9.0 through 3.9.5 Recall Number: Z-0709-2025 REASON: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. RECALLING FIRM/MANUFACTURER: Mint Medical GmbH VOLUME OF PRODUCT IN COMMERCE: 65 units...Read More

Company: Hermes Medical Solutions AB Date of Enforcement Report: 12/12/2024 Class II PRODUCT Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0 Recall Number: Z-0678-2025 REASON: Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. RECALLING FIRM/MANUFACTURER: Hermes...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class II PRODUCT BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 Recall Number: Z-0671-2025 REASON: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2)...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class II PRODUCT BD Pyxis MedStation ES, REF: 323 Recall Number: Z-0670-2025 REASON: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 12/11/2024 Class: II PRODUCT BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 REASON: Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a...Read More

Company: Fresenius Kabi USA Date of Enforcement Report: 12/05/2024 PRODUCT The Ivenix LVP is a large volume infusion pump designed to deliver fluids and medications from one of two inlet source containers to the patient through a single outlet. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient. UDI...Read More

Company: Abbott Medical Date of Enforcement Report: 11/26/2024 Class: III PRODUCT Merlin@home Transmitter REF EX1100 The Merlin@home” (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net” Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device...Read More

Company: Zyno Medical LLC Date of Enforcement Report: 11/22/2024 Class: III PRODUCT Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certified healthcare professional. Recall...Read More

Company: Philips Medical Systems Technologies Ltd. Date of Enforcement Report: 11/20/2024 Class: II PRODUCT Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites. Recall Number: Z-0497-2025...Read More

Company: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Date of Enforcement Report: 11/07/2024 Class II PRODUCT SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography. Recall Number: Z-0316-2025 REASON: X-ray R/F system software with certain versions of the control board may...Read More

Company: Philips North America Llc. Date of Enforcement Report: 10/4/2024 Class II PRODUCT IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 10/16/2024 Class II PRODUCT Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound (IVUS). When used with a peripheral...Read More

Company: Agfa Healthcare NV Date of Enforcement Report: 10/10/2024 Class II PRODUCT Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 10/10/2024 Class II PRODUCT StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Recall Number: Z-0050-2025 REASON: Due to two...Read More

Company: Zyno Medical LLC Date of Enforcement Report: 10/9/2024 Class II PRODUCT Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z Recall Number: Z-0005-2025 REASON: There is a defect in the air-in-line software algorithm. RECALLING FIRM/MANUFACTURER: Zyno...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 10/07/2024 Class II PRODUCT Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Recall Number: Z-0025-2025 REASON: When the DxI 9000 Access Immunoassay Analyzer with...Read More

Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/03/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...Read More

Company: Becton, Dickinson and Company, BD Bio Sciences Date of Enforcement Report: 10/3/2024 Class II PRODUCT BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. Recall Number: Z-0009-2025 REASON: Sample preparation...Read More

Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...Read More

Company: Fisher & Paykel Healthcare, Ltd. Date of Enforcement Report: 9/25/2024 Class II PRODUCT PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute...Read More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 9/24/2024 Class II PRODUCT ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software. Recall Number: Z-3215-2024 REASON: If ultrasound systems with software, are changed from factory default to :...Read More

Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3135-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...Read More

Company: Datascope Corp. Date of Enforcement Report: 9/20/2024 Class I PRODUCT CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. Recall Number: Z-3134-2024 REASON: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of...Read More

Company: Mazor Robotics Ltd Date of Enforcement Report: 9/16/2024 Class II PRODUCT Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Recall Number: Z-3156-2024 REASON: Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw...Read More

Company: Philips Respironics, Inc. Date of Enforcement Report: 9/4/2024 Class I PRODUCT Trilogy Evo EV300 — Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA...Read More

Company: Medtronic Inc. Date of Enforcement Report: 9/13/2024 Class II PRODUCT 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description:...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 8/30/2024 Class: II PRODUCT BD Pyxis QFill Replenishment Station, REF: 138904-01 Recall Number: Z-2947-2024 REASON: Due to software issue, their is a potential when a restock label is printed for a medication stored in a non-CUBIE location, the incorrect bin for the medication is printed on the...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 8/30/2024 Class II PRODUCT BD Pyxis QFill Replenishment Station, REF: 138904-01 Recall Number: Z-2947-2024 REASON: Due to software issue, their is a potential when a restock label is printed for a medication stored in a non-CUBIE location, the incorrect bin for the medication is printed on the...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 8/16/2024 Class II PRODUCT Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump. Recall Number: Z-2581-2024 REASON: The Spectrum WBM may fail to auto-document...Read More

Company: Biointellisense Inc. Date of Enforcement Report: 8/14/2024 Class II PRODUCT BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. Recall Number: Z-2616-2024 REASON: Software anomaly causing the skin temperature...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/9/2024 Class II PRODUCT Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137. Recall Number: Z-2544-2024 REASON: The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the...Read More

Company: Philips North America Llc Date of Enforcement Report: 8/5/2024 Class II PRODUCT IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. Recall...Read More

Company: Smiths Medical ASD Inc. Date of Enforcement Report: 8/2/2024 Class: I PRODUCT CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent...Read More