Company: Philips Medical Systems Nederland B.V. Date of Enforcement Report: 6/12/2025 Class: II PRODUCT Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282;...Read More

Company: Turncare, Inc Date of Enforcement Report: 6/12/2025 Class: II PRODUCT Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix) Recall Number: Z-1967-2025 REASON: A software issue where “low” and “terminal” battery alerts did not display on the screen to the user in specific circumstances when...Read More

Company: Mobius Mobility LLC Date of Enforcement Report: 6/12/2025 Class: II PRODUCT iBOT PMD with software version 01.05.24. Personal Mobility Device. Recall Number: Z-1965-2025 REASON: Software issue that could potentially lead to the device tipping over from Balance Mode. RECALLING FIRM/MANUFACTURER: Mobius Mobility LLC VOLUME: 442 units DISTRIBUTION: US Nationwide distribution in the states of...Read More

Company: QUANTUM SURGICAL SAS Date of Enforcement Report: 6/9/2025 Class: II PRODUCT EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous...Read More

Company: Cardinal Health 200, LLC Date of Enforcement Report: 6/6/2025 Class: II PRODUCT SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Recall Number: Z-1917-2025 REASON: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or...Read More

Company: Zyno Medical LLC Date of Enforcement Report: 6/6/2025 Class: I PRODUCT Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. Recall Number: Z-1865-2025 REASON: Unreleased software versions were installed on distributed devices without verification or validation. RECALLING FIRM/MANUFACTURER: Zyno Medical LLC VOLUME: 613 units DISTRIBUTION:...Read More

Company: Beckman Coulter, Inc. Date of Enforcement Report: 6/5/2025 Class: II PRODUCT DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 Recall Number: Z-1913-2025 REASON: A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being...Read More

Company: Virtual Incision Corporation Date of Enforcement Report: 6/4/2025 Class: II PRODUCT MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3 Recall Number: Z-1905-2025 REASON: The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display...Read More

Design Approval Requirements and Signatures: Navigating 21 CFR 820 and ISO 13485 Medical device manufacturers often struggle with a fundamental question: What signature requirements apply to design input and design output approvals? Understanding how 21 CFR 820 Design Controls and ISO 13485 address design approvals is essential for achieving both compliance and operational efficiency. This...Read More

German court parks four Volkswagen execs in jail over Dieselgate scandal in which software used to test its vehicles’ pollution emissions was intentionally modified to falsify results.Read More

Company: Copan WASP Date of Enforcement Report: 5/21/2025 Class: II PRODUCT PhenoMATRIX Recall Number: Z-1812-2025 REASON: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and...Read More

Company: Copan WASP Date of Enforcement Report: 05/21/2025 Class II PRODUCT PhenoMATRIX Recall Number: Z-1812-2025 REASON: AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and...Read More

Company: Echopixel, Inc. Date of Enforcement Report: 5/21/2025 Class II PRODUCT TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer...Read More

Company: Echopixel, Inc. Date of Enforcement Report: 5/16/2025 Class II PRODUCT True 3D Viewer, Model: EP-00003 Recall Number: Z-1785-2025 REASON: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image...Read More

Company: Echopixel, Inc. Date of Enforcement Report: 5/16/2025 Class II PRODUCT True 3D Viewer, Model: EP-00003 Recall Number: Z-1785-2025 REASON: With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 5/15/2025 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

Company: ICU Medical, Inc. Date of Enforcement Report: 5/14/2025 Class II PRODUCT LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 Recall Number: Z-1763-2025 REASON: Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values...Read More

“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