Recall – MRI image slices missing

Company: GE Healthcare, LLC
Date of Enforcement Report: 10/27/2021
Class II

PRODUCT

SIGNA Premier

Recall Number: Z-0132-2022

SIGNA Architect

Recall Number: Z-0133-2022

SIGNA Pioneer

Recall Number: Z-0134-2022

Discovery MR750w 3.0T

Recall Number: Z-0135-2022

Discovery MR750 3.0T

Recall Number: Z-0136-2022

SIGNA Creator, SIGNA Explorer

Recall Number: Z-0137-2022

SIGNA Voyager

Recall Number: Z-0138-2022

SIGNA Artist

Recall Number: Z-0139-2022

Optima MR450w 1.5T

Recall Number: Z-0140-2022

1.5T SIGNA HDxt MR System

Recall Number: Z-0141-2022

 

REASON

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 8/26/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

11 devices

DISTRIBUTION

U.S. Nationwide and International

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:  June 5-7, 2024
Boston, MA

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

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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: February 12-15, 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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