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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

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imag...

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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR 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
FDA device enforcement

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.

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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour 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
FDA device enforcement

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, SmartS...

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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare MR Vectra 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare MR MAX 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s 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
FDA device enforcement

GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) 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
FDA device enforcement

GE Vscan Extend, being sold as "Vscan Extend Console"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Class IIReported terminated

Distribution: Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,...

Official source
FDA device enforcement

GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Class IIReported terminated

Distribution: Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,...

Official source
FDA device enforcement

GE Vscan Extend, being sold as "Vscan Extend Dual USB"

The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Class IIReported terminated

Distribution: Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,...

Official source

Reasons in these listed records

  • The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
  • The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

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.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

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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