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SIGNA Pioneer Nuclear Magnetic Resonance Imaging System -… recallZ-0876-2020 · 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-0876-2020
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
K143345, K153003, K160621
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 Pioneer 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)

Show the full code information (1k characters)

Mfg. Lot or Serial # System ID To be provided GON4833100 01264 860536MR3T KZTBL1700064TJ 860871MR3T KZTBL1800069TJ RADNETMR1700 KZTBL1800022TJ 508872PMR 01302 RADNETMR1708 KZTBL1900130TJ 301698MR1 KZTBL1900071TJ 704333PIO KZTBL1900110TJ 631751MR KZTBL1900107TJ RADNETMR1707 KZTBL1900121TJ 803936LMCMR2 033-4-1532 281HMI750W To be provided 83199160995 To be provided M24313812 To be provided M2850013 To be provided TP0013MR01 To be provided PNUE04MR02 To be provided TP0008MR07 To be provided 083027823408018 To be provided 083027823888617 To be provided GON4826677 To be provided GON4762453 To be provided B5142305 To be provided ZC0002 To be provided ZC0034 To be provided ZC0001 To be provided ZC0306 To be provided GON4795546 To be provided 222768MR01 To be provided 34340MRS02 To be provided 10627MRS02

Other devices under the same FDA submission

2 devices cleared under K143345, K153003, K160621 — 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

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