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.
5 linked reportsInjury 4Malfunction 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 | 2 | 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 | 1 | 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
5 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 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-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 | code info di |
| 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 | 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 |
| 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 |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-16 | 3002808157-2026-00004 | Injury | Available | exact di |
| 2025-06-10 | 3002808157-2025-00011 | Injury | Available | exact di |
| 2023-07-28 | 3002808157-2023-00005 | Injury | Available | exact di |
| 2019-11-27 | 9383176 | Malfunction | Available | model number |
Showing the most recent 4 of 5 linked reports.
Regulatory clearances
- 510(k)K232494Substantially equivalent (SESE) · 2023-11-14clearance family
- 510(k)K173592Substantially equivalent (SESE) · 2018-02-13clearance family
- 510(k)K162102Substantially equivalent (SESE) · 2016-11-22clearance 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)K130885Substantially equivalent (SESE) · 2013-05-17clearance family
Predicate lineage
- K141977
Cited as predicate by: K143020, K151579, K152283, K152602, K153343, K153447, K161795, K170396, K173617, K190017, K220018
- K151579
- K173592
Cited as predicate by: K181322, K181433, K182299, K183222, K190757, K192924, K200213, K220589
- K232494
Cited as predicate by: K250443
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 |
Similar devices
- Achieva Philips Medical Systems Nederland B.V.
- Base Plate Miyabi Noras MRI products GmbH
- Breast Pad Insert H SatPad™ Sat Pad Inc.
- Breast Pad Insert SatPad™ Sat Pad Inc.
- Screw for C-Arc Noras MRI products GmbH
- Variety 16-Channel Multipurpose Coil 1.5T Noras MRI products GmbH
- "Brainlab Interface Rotating, with Marking ""51""" Noras MRI products GmbH
- "MR compatible tweezers 4,5""" Noras MRI products GmbH
- "MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector" BAYER MEDICAL CARE INC.
- "MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector" BAYER MEDICAL CARE INC.
- "MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector" BAYER MEDICAL CARE INC.
- "MRI Integral ""T"" with Check Valve for MEDRAD® Spectris MR Injector" BAYER MEDICAL CARE INC.
Select up to two to place side-by-side with this device.