“Codethink today announced the publication of its baseline Safety Assessment report for Codethink Trustable Reproducible Linux (CTRL OS). exida’s assessment validates Codethink’s safety argument for use of CTRL OS in safety-critical and mixed-criticality systems up to SIL 3 / ASIL D, and independently confirms that Codethink’s approach satisfies the expectations of both IEC 61508 and...Read More

Company: Tornier S.A.S. Date of Enforcement Report: 5/8/2025 Class II PRODUCT Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement. Recall Number: Z-1738-2025 REASON: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software. RECALLING FIRM/MANUFACTURER: Tornier S.A.S. VOLUME:...Read More

Company: Philips Medical Systems Nederland B.V Date of Enforcement Report: 5/8/2025 Class II PRODUCT IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. Recall Number: Z-1740-2025 REASON: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report....Read More

Company: Remote Diagnostic Technologies Ltd. Date of Enforcement Report: 5/7/2025 Class II PRODUCT Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 Recall Number: Z-1729-2025 REASON: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of...Read More

Company: Spectrum Medical Ltd. Date of Enforcement Report: 4/29/2025 Class II PRODUCT Brand Name: Quantum Informatics – VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population...Read More

Company: Radiometer Medical ApS Date of Enforcement Report: 04/23/2025 Class II PRODUCT Radiometer ABL90 Series – Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series – Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings. Recall Number:...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 04/18/2025 Class II PRODUCT BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI 2HH-1FM, 138906-01; MINI 3HH-1FG, 169-110; MINI 3HH-1FG,...Read More

Company: Medtronic Xomed, Inc. Date of Enforcement Report: 04/18/2025 Class II PRODUCT NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, REF: NIM4CM01RF; PATIENT INTERFACE NIM4CPB1 NIM 4.0, REF: NIM4CPB1; PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, REF: NIM4CPB1RF; SOFTWARE NIM4SWU143 UPGRADE V1.4.3, REF: NIM4SWU143; SOFTWARE NIM4SWU154 UPGRADE V1.5.4,...Read More

Company: Tandem Diabetes Care, Inc. Date of Enforcement Report: 4/11/2025 Class I PRODUCT t:slim X2 Insulin Pump with Interoperable Technology Recall Number: Z-1519-2025 REASON: A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 4/10/2025 Class II PRODUCT Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223 Recall Number: Z-1551-2025 REASON: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. RECALLING FIRM/MANUFACTURER: Siemens Healthcare Diagnostics, Inc. VOLUME: N/A DISTRIBUTION: Domestic:...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 4/9/2025 Class II PRODUCT BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 04/09/2025 Class II PRODUCT BD Pyxis” MedBank” Mini and BD Pyxis” MedBank” Tower, BD Pyxis” MedFlex, BD Pyxis” MedBank” MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings. Recall Number: Z-1545-2025 REASON: Due...Read More

Company: Tornier S.A.S. Date of Enforcement Report: 4/8/2025 Class II PRODUCT stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. Recall Number: Z-1534-2025 REASON: Stryker identified an elevated complaint rate related to difficulties using...Read More

Company: Tornier S.A.S. Date of Enforcement Report: 4/8/2025 Class II PRODUCT stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. Recall Number: Z-1536-2025 REASON: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system...Read More

Company: Medtronic Neuromodulation Date of Enforcement Report: 4/8/2025 Class II PRODUCT Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators. Recall Number: Z-1543-2025 REASON: There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 4/3/2025 Class II PRODUCT DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC)...Read More

IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software Course Dates: TBD COST: 3 Full Days for $2,400.00 (Fully transferable at any time.) This course focuses on ensuring the participants are aware of the relevant standards and US regulations that drive the processes for creating medical device and HealthIT software, and the...Read More

Company: Baxter Healthcare Corporation Date of Enforcement Report: 3/21/2025 Class II PRODUCT Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 Recall Number: Z-1409-2025 REASON: There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. RECALLING FIRM/MANUFACTURER: Baxter Healthcare Corporation VOLUME: 403 units...Read More

SoftwareCPR® Partner and General Manager, Brian Pate, will teach the #aami QSS (Quality System Software) course on April 23rd and 24th, 2025. This course will be hosted by https://www.aami.org/ and runs from 9:00 am EDT to 6:00 pm EDT each day. What is QSS? QSS is all of that software, that is not part of the...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 3/17/2025 Class II PRODUCT BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report: 3/13/2025 Class I PRODUCT BD Alaris Systems Manager, REF 9601 Infusion Safety Management Software Recall Number: Z-1304-2025 REASON: Software issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU). RECALLING FIRM/MANUFACTURER: CareFusion 303, Inc. DISTRIBUTION: US: AZ, CA, DC, FL,...Read More

Company: MIM Software Inc Date of Enforcement Report: 3/04/2025 Class II PRODUCT MIM software; System, Image Processing, Radiological Recall Number: Z-1252-2025 REASON: In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result. RECALLING FIRM/MANUFACTURER:...Read More

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

Improving medical device software development isn’t just about adding or modifying. The simplest approach is to NOT do things that don’t need doing. This is a key theme we cover in our training and consulting. “Faster, better, cheaper” is easier to attain when you do less and reduce complexity. The same applies to safety and...Read More

WARNING LETTER Robbins Instruments, LLC was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 687984 2003 Edwards Street Houston, TX 77007 United States Dates: March 27 through May 31, 2024 Inspection Issue(s): The report states that, “FDA has learned that your firm is marketing the Dermo-Jet Needleless...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

Developing safe and effective medical device software is not easy. Doing that efficiently AND meeting regulatory compliance requirements is even harder. Many companies are implementing agile or lean software development methods to improve results. But can those methods also be compliant at the same time? Yes! There is a caveat, however … agile approaches “out...Read More

The Agile & Compliant February courses have early registration discount deadlines are coming up soon: Americas: 14 January 2025 EU et al: 21 January 2025 Pacific: 28 January 2025 Full details and registration form at https://www.softwarecpr.com/2024/12/1st-quarter-2025-agile-compliant-courses-scheduled/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

Andrea Fox of HealthcareNewsIT (https://www.healthcareitnews.com/) reported on November 27, 2024, that OCR HIPAA enforcement is relatively lite.  When OCR (Office of Civil Rights) had identified serious compliance issues including discovery of security flaws, followup was rare according to the HHS inspector general’s (OIG) audit program review. The OIG review reviewed records from January 2016 through...Read More