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.
4 linked reportsInjury 4
| 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 | 0 | 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 | 1 | 1 |
| 2020-12 | 0 | 1.36 |
| 2021-01 | 1 | 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 | 1 | 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 | 0 | 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 | 1 | 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 | 0 | 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
4 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 |
| 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 |
| 2011-03-03 | Z-2021-2011 | Terminated | Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to become overheated, leading to the emission of smoke and possible material damage. | — | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-08-26 | 3002808157-2025-00023 | Injury | Available | exact di |
| 2022-12-15 | 3002808157-2022-56429 | Injury | Available | exact di |
| 2021-01-21 | MW5098943 | Injury | Available | model number |
| 2020-10-28 | 3002808157-2020-51590 | Injury | Available | exact di |
Regulatory clearances
- 510(k)K130885Substantially equivalent (SESE) · 2013-05-17clearance family
Predicate lineage
Cited as predicate by: K123510, K123920, K123938, K130262, K130749, K132831, K132951, K133692, K140666, K141977, K143020, K152602, K163234, K170396, K170840, K181613, K191050, K220018
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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