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FDA Devices Verify with FDA Devices → Moderate Class II Terminated

GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast,

Reported: October 9, 2013 Initiated: August 13, 2013 #Z-2291-2013 828 (443 US, 385 OUS) units

GE Healthcare, LLC issued this FDA Devices recall on October 9, 2013. Classified as Moderate severity (Class II). Approximately 828 (443 US, 385 OUS) units are affected. The recall was issued because: GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Disc…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-2291-2013) was formally reported on October 9, 2013, with the manufacturer initiating the action on August 13, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. GE Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records indicate 828 (443 US, 385 OUS) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the … Distribution data in the federal record shows the product reached: Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, G…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

828 (443 US, 385 OUS)

Related Recalls

6

6 from same agency

Product Description

GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa¿ MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa¿ MR750 System are similar to those for the Signa¿ HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images spectroscopic images parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Reason for Recall

GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
828 (443 US, 385 OUS)
Distribution
Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Martinique, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, . OUS: AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY.
Location
Waukesha, WI

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2291-2013
Date reported October 9, 2013
Date initiated August 13, 2013
Recalling firm GE Healthcare, LLC
Units affected 828 (443 US, 385 OUS)
Distribution Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

828 (443 US, 385 OUS) units affected — million-unit bracket.

Regional (<10K units) —
Multi-state (10K – 100K units) —
Large-scale (100K – 1M units) —
Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼
GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa¿ MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa¿ MR750 System are similar to those for the Signa¿ HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images spectroscopic images parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.. Recalled by GE Healthcare, LLC. Units affected: 828 (443 US, 385 OUS).
Why was this product recalled? ▼
GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2013. Severity: Moderate. Recall number: Z-2291-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution USA including DC, all states except HI, ND, RI and WY and Internationally to Australia, Bahrain, Belarus, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Martinique, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, . OUS: AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MARTINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, QATAR, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2291-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

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All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).