Day

October 5, 2016
Company: Spacelabs Helathcare Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Recall Number Z-2886-2016 REASON The firm received multiple reports of Xhibit Telemetry System going offline or...
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Company: Spacelabs Helathcare Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Spacelabs Healthcare Xhibit Central Station, Model 96102. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. Recall Number Z-2885-2016 REASON The firm received multiple reports of Xhibit Telemetry System going offline or locking...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo.plaza, Picture Archiving and Communication System. Recall Number Z-2891-2016 REASON Software upgrade to eliminate several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 9/27/2016 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 47 systems DISTRIBUTION...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo.plaza VB10A, Picture Archiving and Communication System Recall Number Z-2892-2016 REASON Software upgrade to eliminate several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Malvern, PA on 9/27/2016 Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 47 systems...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT RTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Recall Number Z-2877-2016 REASON Software patch installation to address several...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 10/5/2016 Class lI: PRODUCT ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Recall Number Z-2876-2016 REASON Software patch installation to address several...
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Company: Medtronic Inc. Date of Enforcement Report 10/5/2016 Class lI: PRODUCT CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study...
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Company: CareFusion 303 Inc.Date of Enforcement Report 10/52016 Class lI: PRODUCT Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can...
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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 with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  June 24-26, 2025 (Virtual, Live)

For private, in-house courses, please contact us.

Email training@softwarecpr.com for more info.

 


 

Being Agile & Yet Compliant (Public)

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

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

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

  • TBD
See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

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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