GE Healthcare, LLC recall records

54 reported ongoing

65 records in this archive. Latest source date Feb 27, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System

There is potential for the images to be flipped left to right.

Class IIReported ongoing

Distribution: Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong...

Official source for 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance...
FDA device enforcement

GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.

If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.

Class IIReported ongoing

Distribution: Worldwide distribution - US nationwide, including Puerto Rico. There was also government/military distribution. The countries of Algeria, Argentina, Australia, Austria, Bahrain,...

Official source for GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MA...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nucl...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nu...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nucl...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T Syst...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T Syste...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic reson...

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomog...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Ex...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR36...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclea...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Vo...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nucle...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T syste...
FDA device enforcement

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....

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIG...
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.

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

Class IIReported ongoing

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...

Official source for GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR Sy...

Reasons in these listed records

  • There is potential for the images to be flipped left to right.
  • If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
  • The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

These examples come from this result page and are not a ranking of every recall reason.

Checking GE Healthcare, LLC

Is there a recall on ge healthcare, llc right now?

This archive contains 65 records, including 54 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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What if the search finds no matching record?

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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