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SIGNA Premier Nuclear Magnetic Resonance Imaging System -… recallZ-0874-2020 · GE Healthcare, LLC · initiated Dec 23, 2019

Class II Terminated All recalls posted in January 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system's date and time setting are used to populate the DICOM header information on images. This could result is an inaccurate date recorded on the images.

FDA root cause category: Software design

What the company is doing

This issue will be resolved by sending an Urgent Medical Device Correction letter to Medical Facility staff (Director of Clinical/Radiology, Risk Manager/Hospital Administrator, Director of Biomedical Engineering) with affected systems. This letter will inform the customer of the issue and instruct the user to ensure the displayed system date is correct. The long-term solution is to correct affected systems with updated software.

Recall details

Recall number
Z-0874-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 23, 2019
Posted by the FDA
Jan 28, 2020
Recalling firm
GE Healthcare, LLC
Quantity
62 (30 US, 32 OUS) total devices
Product code
LNH
FDA submissions
K171128
Distribution
Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Product description

SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Code information (models, lots, serial numbers)

Mfg. Lot or Serial# System ID 33-4-1031 415723SHMR19 To be provided RTD01204 To be provided DPN88672

Other devices under the same FDA submission

1 device cleared under K171128 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84655).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page