Device recall: GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic…

Class II FDA enforcement event 89376. Recall start date: 23 Dec 2021. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

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 23 Dec 2021. The firm address in the FDA record is in Waukesha, WI. FDA put the recall in Class II. FDA event 89376 has 32 product records. The first FDA enforcement report date is 16 Feb 2022. The record gives the status Ongoing.

FDA enforcement report The 32 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.

Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign distribution was made to Albania, Algeria, Argentina, Armenia,…

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

32 product records in the event.

FDA event 89376: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0590-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0591-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0592-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0593-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0594-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0595-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0596-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0597-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0598-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0599-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0600-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0601-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0602-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0603-2022	GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance…	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0604-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0605-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0606-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0607-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0608-2022	GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0609-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0610-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0611-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0612-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0613-2022	GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0614-2022	GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0615-2022	GE Healthcare MR superconducting magnets, a component of GE SIGNA Excite 1.5T MR System, GE SIGNA Excite 3.0T MR System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0616-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0617-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0618-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0619-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0620-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022
Z-0621-2022	GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.	17,228 devices total in this field correction	Class II	Ongoing	16 Feb 2022

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: 32Median 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-0590-2022The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 89376. https://recallregister.com/fda/ii/89376/. 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: Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign distribution was made to Albania, Algeria, Argentina, Armenia,…
What quantity of product is in FDA event 89376?: The event has 32 product records. The first record gives this quantity: 17,228 devices total in this field correction
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.