By

Allison Pate
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...
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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...
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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...
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FDA will host a webinar to discuss Cybersecurity quality system considerations on Tuesday, June 14, 2022, from 1 p.m. to 2:15 p.m. EDT.  The webinar will focus on the latest and current Cybersecurity Premarket Submissions draft guidance released in April 2022.  This draft guidance replaces the 2018 draft version and is intended to further emphasize the...
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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...
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Company: Bio-Rad Labratories, Inc. Date of Enforcement Report: 5/28/2022 Class II PRODUCT Sickle Cell Program Resin CD-ROM Recall Number: Z-1208-2022 REASON The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific...
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In February 2022, the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745, released revision 1 of MDCG 2021-21, Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.  You can view the copy at this link: MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical...
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Company: Align Technology Inc Date of Enforcement Report: 01/26/2023 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...
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Company: Olympus Corporation of the Americas Date of Enforcement Report: June 30, 2021 Class II PRODUCT Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological...
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Company: New Star Lasers, Inc. Date of Enforcement Report: June 27, 2015 Class II PRODUCT StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. Recall Number:...
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SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

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