Device recall: SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high…

Class II FDA enforcement event 88147. Recall start date: 4 Jun 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" button. This changes the prescribed patient orientation on the system prior to running the initial 3-Plane Localizer Scan (See Figure 1 for reference to buttons.) Selecting and saving a patient…

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

GE Healthcare, LLC started this device recall on 4 Jun 2021. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class II. FDA event 88147 has 14 product records. The first FDA enforcement report date is 21 Jul 2021. The record gives the status Ongoing.

FDA enforcement report The 14 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distributions.

Recalling firm

GE Healthcare, LLC, Waukesha, WI.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

14 product records in the event.

FDA event 88147: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2052-2021	SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.	100 devices	Class II	Ongoing	21 Jul 2021
Z-2053-2021	SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.	311 devices	Class II	Ongoing	21 Jul 2021
Z-2054-2021	SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.	460 units	Class II	Ongoing	21 Jul 2021
Z-2055-2021	Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.	585 devices	Class II	Ongoing	21 Jul 2021
Z-2056-2021	Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.	248 units	Class II	Ongoing	21 Jul 2021
Z-2057-2021	SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	71 devices	Class II	Ongoing	21 Jul 2021
Z-2058-2021	SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System	1737 devices	Class II	Ongoing	21 Jul 2021
Z-2059-2021	SIGNA MR355, SIGNA MR360, Nuclear Magnetic Resonance Imaging System	242 units	Class II	Ongoing	21 Jul 2021
Z-2060-2021	SIGNA MR380, Nuclear Magnetic Resonance Imaging System		Class II	Ongoing	21 Jul 2021
Z-2061-2021	SIGNA Artist, Nuclear Magnetic Resonance Imaging System	562 devices	Class II	Ongoing	21 Jul 2021
Z-2062-2021	SIGNA Voyager, Nuclear Magnetic Resonance Imaging System	541 devices	Class II	Ongoing	21 Jul 2021
Z-2063-2021	Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System	1519 units	Class II	Ongoing	21 Jul 2021
Z-2064-2021	Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System	40 units	Class II	Ongoing	21 Jul 2021
Z-2065-2021	1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System	91 units	Class II	Ongoing	21 Jul 2021

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2021: 900
Share of these events in Class II: 89%
Product records in this event: 14Median of the firm: 1
Events of the firm on the register: 225

Other events of the firm

Other FDA enforcement events of GE Healthcare, LLC
Initiated	Product (first record)	Type	Class	Records
27 Feb 2026	SIGNA Premier systems	Device	Class II	1
15 Jul 2022	(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3	Device	Class II	1
24 Jun 2022	SIGNA Premier magnetic resonance scanner, model 5748519.	Device	Class II	1
14 Jun 2022	Centricity PACS Software Version 7.0 SP0.0.4.7	Device	Class II	1
8 Jun 2022	GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within	Device	Class II	1
2 Jun 2022	Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Cap	Device	Class II	1
1 Jun 2022	GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia Syste	Device	Class I	1
27 May 2022	GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part	Device	Class II	1
10 May 2022	CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and	Device	Class II	1
28 Apr 2022	Centricity Universal Viewer Zero Footprint Client	Device	Class II	5

GE Healthcare, LLC: all 225 events

Official channels

FDA enforcement report Z-2052-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 88147. https://recallregister.com/fda/ii/88147/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distributions.
What quantity of product is in FDA event 88147?: The event has 14 product records. The first record gives this quantity: 100 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.