Severity
Moderate
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant
Reported: April 27, 2022 Initiated: March 4, 2022 #Z-0983-2022 18,411 systems units
GE Healthcare, LLC issued this FDA Devices recall on April 27, 2022. Classified as Moderate severity (Class II). Approximately 18,411 systems units are affected. The recall was issued because: During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transporta…. 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-0983-2022) was formally reported on April 27, 2022, with the manufacturer initiating the action on March 4, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. GE Healthcare, LLC is listed as the recalling firm, operating out of Waukesha, WI. Federal records indicate 18,411 systems units are affected.
The documented reason for this recall is: During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan, Bahrain, Banglade…. 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 4 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
Units Affected
18,411 systems
Related Recalls
6
6 from same agency
Product Description
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.
Reason for Recall
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 18,411 systems
- Distribution
- Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Republic of Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrhyzstan, Latvia, Lebanon, Libyan Arabic Jamahiriya, Lithuania, Luxembourg, Macedonia, Madagascar, Malawi, Malaysia, Mali, Malta, Mauritania, Mexico, Republic of Moldova, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Nordic-HQ, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.
- Location
- Waukesha, WI
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0983-2022 |
| Date reported | April 27, 2022 |
| Date initiated | March 4, 2022 |
| Recalling firm | GE Healthcare, LLC |
| Units affected | 18,411 systems |
| Distribution | Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.. Recalled by GE Healthcare, LLC. Units affected: 18,411 systems.
Why was this product recalled? ▼
During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to potential injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0983-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide), including Puerto Rico and the U.S. Virgin Islands; and OUS (Foreign) was made to Albania, Algeria, Argentina, Armenia, ASEAN HQ, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Republic of Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Kyrhyzstan, Latvia, Lebanon, Libyan Arabic Jamahiriya, Lithuania, Luxembourg, Macedonia, Madagascar, Malawi, Malaysia, Mali, Malta, Mauritania, Mexico, Republic of Moldova, Morocco, Mozambique, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Nordic-HQ, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0983-2022) 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.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
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).