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.
3 linked reportsInjury 2Malfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.29 |
| 2019-04 | 0 | 3.05 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 2.13 |
| 2019-10 | 0 | 1.42 |
| 2019-11 | 1 | 1 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1.25 |
| 2020-07 | 0 | 1.69 |
| 2020-08 | 0 | 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 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1.43 |
| 2022-03 | 0 | 1.14 |
| 2022-04 | 0 | 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 | 0 | 1 |
| 2023-02 | 0 | 1.25 |
| 2023-03 | 0 | 2.81 |
| 2023-04 | 0 | 1.57 |
| 2023-05 | 0 | 1.77 |
| 2023-06 | 0 | 1.43 |
| 2023-07 | 1 | 1.39 |
| 2023-08 | 0 | 2.33 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.79 |
| 2023-11 | 0 | 2.22 |
| 2023-12 | 0 | 1.17 |
| 2024-01 | 0 | 1.17 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.25 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 0 | 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 | 0 | 1.22 |
| 2025-01 | 0 | 4.67 |
| 2025-02 | 0 | 3.29 |
| 2025-03 | 0 | 2.41 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 2.36 |
| 2025-06 | 0 | 4.95 |
| 2025-07 | 0 | 5.46 |
| 2025-08 | 0 | 7.53 |
| 2025-09 | 0 | 4.34 |
| 2025-10 | 0 | 5.1 |
| 2025-11 | 0 | 3.92 |
| 2025-12 | 0 | 7 |
| 2026-01 | 0 | 6.47 |
| 2026-02 | 1 | 3.8 |
| 2026-03 | 0 | 3.44 |
| 2026-04 | 0 | 3.62 |
| 2026-05 | 0 | 6.38 |
| 2026-06 | 0 | 3 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 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 |
| 2025-08-28 | Z-2662-2025 | 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. | 39 units | code info di |
| 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 |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-16 | 3002808157-2026-00005 | Injury | Available | exact di |
| 2023-07-28 | 3002808157-2023-00005 | Injury | Available | procode brand trgm |
| 2019-11-27 | 9383176 | Malfunction | Available | procode brand trgm |
Regulatory clearances
- 510(k)K250443Substantially equivalent (SESE) · 2025-06-16clearance family
- 510(k)K220589Substantially equivalent (SESE) · 2022-05-13clearance family
Predicate lineage
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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