Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
52 linked reportsInjury 48Malfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 4 | 2.29 |
| 2019-04 | 9 | 3.05 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 4 | 2.13 |
| 2019-10 | 2 | 1.42 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1.25 |
| 2020-07 | 2 | 1.69 |
| 2020-08 | 4 | 4 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-12 | 0 | 1.36 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-04 | 0 | 3 |
| 2021-05 | 0 | 1 |
| 2021-07 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.29 |
| 2021-10 | 0 | 1.38 |
| 2021-11 | 0 | 1 |
| 2021-12 | 1 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1.43 |
| 2022-03 | 0 | 1.14 |
| 2022-04 | 1 | 1 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1.29 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 1.33 |
| 2022-10 | 0 | 1.2 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1.31 |
| 2023-01 | 1 | 1 |
| 2023-02 | 0 | 1.25 |
| 2023-03 | 0 | 2.81 |
| 2023-04 | 0 | 1.57 |
| 2023-05 | 1 | 1.77 |
| 2023-06 | 0 | 1.43 |
| 2023-07 | 0 | 1.39 |
| 2023-08 | 3 | 2.33 |
| 2023-09 | 0 | 2 |
| 2023-10 | 3 | 1.79 |
| 2023-11 | 3 | 2.22 |
| 2023-12 | 1 | 1.17 |
| 2024-01 | 0 | 1.17 |
| 2024-02 | 0 | 1 |
| 2024-03 | 1 | 1.25 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 1 | 1 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.4 |
| 2024-08 | 0 | 1.69 |
| 2024-09 | 0 | 1.25 |
| 2024-10 | 0 | 1.33 |
| 2024-11 | 0 | 1.89 |
| 2024-12 | 1 | 1.22 |
| 2025-01 | 1 | 4.67 |
| 2025-02 | 0 | 3.29 |
| 2025-03 | 0 | 2.41 |
| 2025-04 | 0 | 2 |
| 2025-05 | 1 | 2.36 |
| 2025-06 | 1 | 4.95 |
| 2025-07 | 1 | 5.46 |
| 2025-08 | 0 | 7.53 |
| 2025-09 | 1 | 4.34 |
| 2025-10 | 1 | 5.1 |
| 2025-11 | 2 | 3.92 |
| 2025-12 | 0 | 7 |
| 2026-01 | 0 | 6.47 |
| 2026-02 | 0 | 3.8 |
| 2026-03 | 0 | 3.44 |
| 2026-04 | 1 | 3.62 |
| 2026-05 | 1 | 6.38 |
| 2026-06 | 0 | 3 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-08-28 | Z-2667-2025 | Class I | Open, Classified | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa. | 498 units | clearance family |
| 2025-08-28 | Z-2658-2025 | Class I | Open, Classified | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa. | 130 units | clearance family |
| 2025-08-28 | Z-2659-2025 | Class I | Open, Classified | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa. | 101 units | clearance family |
| 2025-08-28 | Z-2660-2025 | Class I | Open, Classified | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa. | 586 units | clearance family |
| 2025-08-28 | Z-2661-2025 | Class I | Open, Classified | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.Distribution: Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Armenia, Angola, Argentina, Austria, Australia, Azerbaijan, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Brunei Darussalam, Brazil, Botswana, Belarus, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czechia, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Ethiopia, Finland, Faroe Islands, France, United Kingdom of Great Britian and Northern Ireland, Georgia, Greece, Hong Kong, Croatia, Hungary, Canary Islands, Indonesia, Ireland, Israel, India, Iran, Iceland, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Morocco, Monaco, Moldova, Montenegro, Republic of North Macedonia, Myanmar, Mongolia, Macao, Malta, Maldives, Mexico, Malaysia, Mozambique, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Senegal, Syrian Arab Republic, Thailand, Turkmenistan, Tunisia, Turkey, Trinidad and Tobago, Taiwan, Tanzania, Ukraine, Uganda, Uzbekistan, Viet Nam, Kosovo, South Africa. | 56 units | clearance family |
| 2023-09-01 | Z-2648-2023 | Class II | Open, Classified | In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters usedDistribution: US Nationwide distribution. | 3,470 units US; 13,265 worldwide | code info di |
| 2019-07-09 | Z-2342-2019 | Class II | Terminated | Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.Distribution: AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY | 143 | clearance family |
| 2019-07-09 | Z-2343-2019 | Class II | Terminated | Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly.Distribution: AL AR AZ CA CO CT DC DE FL GA GU IA ID IL IN KS KY LA MA MD ME MI MN MO MT NC NE NH NJ NY OH OK OR PA SC TN TX VA WA WI WV WY | 44 | clearance family |
| 2015-12-07 | Z-0467-2016 | Class II | Terminated | Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be blown directly into the magnet room or other areas. This could lead to displacement of oxygen, cause cold burns, and/or pose a risk to users, patient or others.Distribution: Nationwide including : DC, PR, Virgin Islands and Bermuda | in US 3752 units | clearance family |
| 2014-04-24 | Z-1663-2014 | Class II | Terminated | Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals.Distribution: Distributed in the states of MN, CA, CO, TX, and IA. | 5 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-29 | 3002808157-2026-00014 | Injury | Available | exact di |
| 2026-04-17 | 3002808157-2026-00012 | Injury | Available | exact di |
| 2025-11-17 | 3002808157-2025-00039 | Injury | Available | exact di |
| 2025-11-17 | 3002808157-2025-00038 | Malfunction | Available | exact di |
| 2025-10-16 | 3002808157-2025-00029 | Injury | Available | exact di |
| 2025-09-05 | 3002808157-2025-00024 | Injury | Available | exact di |
| 2025-07-02 | 3002808157-2025-00014 | Malfunction | Available | exact di |
| 2025-06-30 | 3002808157-2025-00013 | Injury | Available | exact di |
| 2025-05-14 | 3002808157-2025-00006 | Injury | Available | exact di |
| 2025-01-31 | 3002808157-2025-00002 | Injury | Available | exact di |
| 2024-12-30 | 3002808157-2024-00017 | Injury | Available | exact di |
| 2024-05-07 | 3002808157-2024-00007 | Injury | Available | exact di |
| 2024-03-12 | 3002808157-2024-00004 | Injury | Available | exact di |
| 2023-12-11 | 3002808157-2023-00016 | Injury | Available | exact di |
| 2023-11-22 | 3002808157-2023-00015 | Injury | Available | exact di |
Showing the most recent 34 of 52 linked reports.
Showing 1–15 of 34
Regulatory clearances
- 510(k)K231560Substantially equivalent (SESE) · 2023-10-23clearance family
- 510(k)K202014Substantially equivalent (SESE) · 2020-09-08clearance family
- 510(k)K191050Substantially equivalent (SESE) · 2019-07-12clearance family
- 510(k)K190138Substantially equivalent (SESE) · 2019-02-15clearance family
- 510(k)K182299Substantially equivalent (SESE) · 2018-10-26clearance family
- 510(k)K173592Substantially equivalent (SESE) · 2018-02-13clearance family
- 510(k)K163312Substantially equivalent (SESE) · 2017-01-27clearance family
- 510(k)K141977Substantially equivalent (SESE) · 2014-11-19clearance family
- 510(k)K142515Substantially equivalent (SESE) · 2014-10-08clearance family
- 510(k)K140253Substantially equivalent (SESE) · 2014-03-20clearance family
- 510(k)K133435Substantially equivalent (SESE) · 2013-12-12clearance family
- 510(k)K132951Substantially equivalent (SESE) · 2013-11-15clearance family
- 510(k)K111242Substantially equivalent (SESE) · 2011-11-23clearance family
Predicate lineage
- K141977
Cited as predicate by: K143020, K151579, K152283, K152602, K153343, K153447, K161795, K170396, K173617, K190017, K220018
- K153343
Cited as predicate by: K163211, K163234, K163294, K163312, K170396, K170840, K173592, K173600, K181322, K181433, K181613, K182129, K191050, K192496, K193324, K202014, K250443
- K173592
Cited as predicate by: K181322, K181433, K182299, K183222, K190757, K192924, K200213, K220589
- K182299
Cited as predicate by: K203443, K210611, K231587, K232322, K232482, K232765
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2014-09-25 | NAI | No action indicated | Siemens AG/Siemens Healthcare GmbH | 0 |
| 2011-06-09 | VAI | Voluntary action indicated | Siemens Healthcare GmbH | 1 |
| 2010-09-14 | NAI | No action indicated | Siemens AG/Siemens Healthcare GmbH | 0 |
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