Company: Beckman Coulter Biomedical GmbH Date of Enforcement Report: 07/14/2023 Class II PRODUCT Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly Recall Number: Z-2144-2023 REASON: A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 07/13/2023 Class I PRODUCT SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 Recall Number: Z-2103-2023 REASON: A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported...Read More

Company: RaySearch America Inc Date of Enforcement Report: 07/03/2023 Class II PRODUCT Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. Recall Number: Z-2039-2023 REASON: A software bug affecting results when...Read More

Company: Philips North America Llc Date of Enforcement Report: 06/29/2023 Class II PRODUCT DigitalDiagnost C90, Model No. 712034 and 712035 Recall Number: Z-2042-2023 REASON: There is a software login in issue that may prevent the user from logging in. RECALLING FIRM/MANUFACTURER: Philips North America Llc VOLUME OF PRODUCT IN COMMERCE: 58 DISTRIBUTION: Distribution in US:...Read More

Company: Appliedvr Date of Enforcement Report: 06/29/2023 Class II PRODUCT RelieVR REF: RVX-2002, Rx Only Recall Number: Z-2044-2023 REASON: There is the potential for the program software to malfunction which will not allow it to move forward to the next session. RECALLING FIRM/MANUFACTURER: Appliedvr VOLUME OF PRODUCT IN COMMERCE: 1 unit DISTRIBUTION: US: NY OUS:...Read More

Company: SenTec AG Date of Enforcement Report: 06/20/2023 Class II PRODUCT V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). Recall Number: Z-1980-2023 REASON: The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode “production” and were not reset to “released” mode. RECALLING...Read More

Company: Illumina, Inc. Date of Enforcement Report: 06/16/2023 Class II PRODUCT NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software Recall Number: Z-1976-2023 REASON: Cybersecurity vulnerability concerning the software used for sequencing instruments. RECALLING FIRM/MANUFACTURER: Illumina, Inc. VOLUME OF PRODUCT IN COMMERCE: 1067 units DISTRIBUTION: Worldwide distribution – US Nationwide and the countries...Read More

Company: Datascope Corp. Date of Enforcement Report: 06/14/2023 Class III PRODUCT Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX Recall Number: Z-1907-2023 REASON: The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU. RECALLING FIRM/MANUFACTURER: Datascope...Read More

Company: BioReference Health, LLC Date of Enforcement Report: 06/02/2023 Class II PRODUCT The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Recall Number: Z-1666-2023 REASON: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems Recall Number: Z-1666-2023 REASON: In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance...Read More

Company: BioReference Health, LLC Date of Enforcement Report: 06/02/2023 Class II PRODUCT The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report: 06/02/2023 Class I PRODUCT StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems Recall Number: Z-1630-2023 REASON: During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other...Read More

Company: Hamilton Medical AG Date of Enforcement Report: 4/25/2023 Class II PRODUCT HAMILTON-C6, REF: 160021 Recall Number: Z-1429-2023 REASON: Software error causes, safety ventilation malfunction, in which ventilation continues in the “safety ventilation” mode with audible/visible alarm – patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode...Read More

Company: Spacelabs Healthcare, Inc Date of Enforcement Report: 4/12/2023 Class II PRODUCT Ultraview SL (UVSL) Command Module, Model 91496 Recall Number: Z-1503-2023 REASON: Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with...Read More

Company: Outset Medical, Inc. Date of Enforcement Report: 4/07/2023 Class II PRODUCT Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. Recall Number: Z-1351-2023 REASON: An...Read More

Company: Shanghai United Imaging Healthcare Co., Ltd Date of Enforcement Report: 4/7/2023 Class II PRODUCT Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 Recall Number: Z-1353-2023 REASON: Due to a software issue where the process of patient scanning, the scatter correction may...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 3/01/2023 Class II PRODUCT Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255 Recall Number: Z-1192-2023 REASON: Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new...Read More

Company: Stryker Corporation Date of Enforcement Report: 2/27/2023 Class II PRODUCT Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss. RECALL NUMBER: Z-1184-2023 REASON: Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output...Read More

Company: Getinge Usa Sales Inc Date of Enforcement Report: 1/26/2023 Class I PRODUCT Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400 Programmable Diagnostic Computer Recall Number: Z-0959-2023 REASON Due to a software bug, under certain conditions, pressure cannot be built up resulting in no...Read More

Company: Align Technology Inc. Date of Enforcement Report: 1/26/2023 Class II PRODUCT Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 Recall Number: Z-1017-2023 REASON 3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than...Read More

Company: Agfa Healthcare NV Date of Enforcement Report: 1/20/2023 Class II PRODUCT Agfa HealthCare Enterprise Imaging XERO Viewer Recall Number: Z-0775-2023 REASON There is a software defect that can cause issues with images. RECALLING FIRM/MANUFACTURER Agfa Healthcare NV VOLUME OF PRODUCT IN COMMERCE 110 units DISTRIBUTION Distribution throughout US OUS distribution to Australia, Belgium, Brazil,...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report: 01/06/2023 Class II PRODUCT Devices Recall Number: Z-0911-2023 REASON Software anomalies, CP App messages: “Too Many Device Found”, “Unexpected Device Error Code 1502”, and “System Update Needed, Service Code 303” RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation VOLUME OF PRODUCT IN COMMERCE 440 units DISTRIBUTION Worldwide distributionRead More

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 12/31/2022 Class II PRODUCT Programmable Diagnostic Computer Recall Number: Z-0775-2023 REASON The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) “PASSWORD STORE CORRUPTED” error message during system boot;...Read More

Company: Fresenius Medical Care Holdings, Inc. Date of Enforcement Report:12/20/202 Class II PRODUCT 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126...Read More

Company: Abbott Molecular, Inc. Date of Enforcement Report: 11/18/2022 Class II PRODUCT Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use Recall Number: Z-0268-2023 REASON Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when...Read More

Company:Boston Scientific Corporation Date of Enforcement Report: 10/31/2022 Class II PRODUCT ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 Recall Number: Z-0151-2023 REASON There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc VOLUME OF PRODUCT IN COMMERCE 7 devices...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 10/21/2022 Class II PRODUCT ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 Recall Number: Z-0119-2023 REASON Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment...Read More

Company: Fresenius Kabi USA, LLC Date of Enforcement Report: 10/6/2022 Class I PRODUCT Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 Recall Number: Z-0002-2023 REASON The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification....Read More

Company: Micro-X Ltd. Date of Enforcement Report: 9/23/2022 ClassII PRODUCT MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Recall Number: Z-1786-2022 REASON Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions RECALLING FIRM/MANUFACTURER Micro-X Ltd....Read More

Company: Cardiac Assist, Inc Date of Enforcement Report: 9/23/2022 Class I PRODUCT Devices Recall Number: Z-1763-2022 REASON Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. RECALLING FIRM/MANUFACTURER Cardiac Assist, Inc VOLUME OF PRODUCT IN COMMERCE 723 units (484 currently in field) DISTRIBUTION US Nationwide...Read More

Company: Zap Surgical Systems Date of Enforcement Report: 9/14/2022 Class II PRODUCT ZAP-X Radiosurgery System Recall Number: Z-1742-2022 REASON Software issue identified in cases of initial patient setup with large (greater-than-or-equal-to 1.5 degrees) rotational deviations, between digitally reconstructed radiographs, and pre-delivery X-ray images. In these cases the transitional alignment algorithm may incorrectly calculate the new...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 9/1/2022 Class II PRODUCT The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator. Recall Number: Z-1669-2022 REASON There is potential...Read More

Company: Oculus Optikgeraete GMBH Date of Enforcement Report: 9/1/2022 Class II PRODUCT Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Recall Number: Z-1672-2022 REASON Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs RECALLING FIRM/MANUFACTURER...Read More

Company: Boston Scientific Corporation Date of Enforcement Report: 9/1/2022 Class II PRODUCT Programmer/Recorder/Monitor (PRM) Recall Number: Z-1669-2022 REASON There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators. RECALLING FIRM/MANUFACTURER Boston Scientific Corporation VOLUME OF...Read More

Company: Aggredyne, Inc. Date of Enforcement Report: 8/26/2022 Class II PRODUCT AggreGuide A-100 Instrument Recall Number: Z-1639-2022 REASON The firm identified a software design issue where the improper shut down of the instrument resulted in speeds.csv file contents of the software version 5.1 being erased. Due to this issue, the target RPM for the assay...Read More

Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 8/11/2022 Class II PRODUCT cobas e801 Immunoassay Analyzer Recall Number: Z-1515-2022 REASON Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG. RECALLING...Read More

Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 8/11/2022 CLASS: II PRODUCT Xhibit Telemetry Receiver, Model: 96280 Recall Number: Z-1513-2022 REASON Software related alarm escalation defect occurs after approximately 25 days of continuous use. Technical alarm escalation for the following alarms, signal loss, all leads off, low battery, SpO2 sensor off, and signal interference, does...Read More

Company: St. Jude Medical, Cardiac Rhythm Management Division Date of Enforcement Report: 8/2/2022 Class II PRODUCT Merlin PCS 3650 programmer Model 3330 software Recall Number: Z-1495-2022 REASON There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers. RECALLING FIRM/MANUFACTURER St. Jude...Read More

Company: Sight Diagnostics LTD Date of Enforcement Report: 7/27/2022 Class II PRODUCT Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 Recall Number: Z-1469-2022 REASON The default reference ranges for MCH, MCHC, and RDW for age group “Child 2-11y” are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due...Read More

Company: GE Healthcare, LLC Date of Enforcement Report: 7/25/2022 Class II PRODUCT Centricity PACS Software Version 7.0 SP0.0.4.7 Recall Number: Z-1466-2022 REASON The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC VOLUME OF PRODUCT IN COMMERCE 47 installations...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 7/22/2022 Class I PRODUCT ABACUS TPN (Total Parenteral Nutrition) Calculation software Recall Number: Z-1376-2022 REASON There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation. Voluntary. Firm Initiated. VOLUME OF PRODUCT IN COMMERCE 9 units...Read More

Company: Baxter Healthcare Company Date of Enforcement Report: 7/22/2022 Class I PRODUCT ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: June 22, 2022 Class: I PRODUCT Abacus Order Entry and Calculation Software Recall Number: Z-1376-2022   REASON There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. RECALLING FIRM/MANUFACTURER Baxter Healthcare Corporation VOLUME OF PRODUCT IN COMMERCE 9 units DISTRIBUTION...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report: 7/21/2022 Class II PRODUCT Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561 Recall Number: Z-1452-2022 REASON Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication...Read More

Company: Becton, Dickinson and Company Date of Enforcement Report: 6/22/2022 Product: Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, Intraosseous Powered Drivers Reason: Product issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries Recalling Firm/Manufactuer: BD (Becton, Dickinson and Company) on 6/22/2022. Voluntary:...Read More

Company: Dynex Technologies, Inc. Date of Enforcement Report: 7/5/2020 Class II PRODUCT DYNEX Agility, Agility Analyzer, Model No. 67000 Recall Number: Z-1222-2022 REASON Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay’s SmartKit will...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 6/30/2022 Class II PRODUCT NaviCare Nurse Call/Voalte Nurse Ca Recall Number: Z-1306-2022 REASON An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call...Read More

Company: Haemonetics Corporation Date of Enforcement Report: 6/28/2022 Class II PRODUCT Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay – PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 6/6/2022 Class II PRODUCT Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620 Recall Number: Z-1243-2022 REASON Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a...Read More