CLASS II Device recall · Reported 5 Feb 2020 · FDA Enforcement Report
Signa Pioneer Nuclear Magnetic Resonance Imaging System recalled
GE Healthcare is recalling Signa Pioneer Nuclear Magnetic Resonance Imaging System, distributed nationwide in the US. The recall was initiated on 23 Dec 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0876-2020
- FDA event ID
- 84655
- Recalling firm
- GE Healthcare, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2019
- FDA classified
- 28 Jan 2020
- Reported
- 5 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Imaging Equipment
Timeline
| 23 Dec 2019 | Recall initiated by company | |
| 28 Jan 2020 | Classified by FDA | +36 days |
| 5 Feb 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US nationwide distribution and countries of Australia, China, France, Germany, India, Italy, Japan, Netherlands, Oman, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 84655This product is part of a recall event; the main page for the event is Signa Architect Nuclear Magnetic Resonance Imaging System recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Signa Architect Nuclear Magnetic Resonance Imaging System recalled | GE Healthcare | Labeling Errors | Nationwide | |
| CLASS II | Signa Premier Nuclear Magnetic Resonance Imaging System recalled | GE Healthcare | Labeling Errors | Nationwide | |
| CLASS II | Signa Vibrant Nuclear Magnetic Resonance Imaging System recalled | GE Healthcare | Labeling Errors | Nationwide |
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