Guiding clients to effective and efficient compliance and regulatory approvals

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...
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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.
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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...
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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...
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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...
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“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...
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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:...
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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....
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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...
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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...
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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:...
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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,...
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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,...
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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...
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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:...
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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...
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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...
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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...
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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...
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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...
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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)...
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SoftwareCPR Training
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...
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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...
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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...
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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...
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SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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