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 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.5 |
| 2019-04 | 0 | 2.75 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-07 | 0 | 2 |
| 2019-10 | 0 | 1.4 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-07 | 0 | 1.6 |
| 2020-08 | 0 | 4 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2020-12 | 0 | 1.5 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-07 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.33 |
| 2021-10 | 0 | 1.33 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1.75 |
| 2022-03 | 0 | 1.13 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1.33 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 1.25 |
| 2022-10 | 0 | 1.17 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1.33 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 1.33 |
| 2023-03 | 0 | 2.9 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 1.9 |
| 2023-06 | 0 | 1.5 |
| 2023-07 | 0 | 1.38 |
| 2023-08 | 0 | 2.17 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 1.57 |
| 2023-11 | 0 | 2 |
| 2023-12 | 0 | 1.2 |
| 2024-01 | 0 | 1.2 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.33 |
| 2024-08 | 0 | 1.5 |
| 2024-09 | 0 | 1.17 |
| 2024-10 | 1 | 1.33 |
| 2024-11 | 0 | 1.78 |
| 2024-12 | 0 | 1.21 |
| 2025-01 | 0 | 4.86 |
| 2025-02 | 0 | 3.38 |
| 2025-03 | 0 | 2.36 |
| 2025-04 | 0 | 2 |
| 2025-05 | 1 | 2.35 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 5.64 |
| 2025-08 | 0 | 7.95 |
| 2025-09 | 0 | 4.53 |
| 2025-10 | 0 | 5.21 |
| 2025-11 | 0 | 4.11 |
| 2025-12 | 0 | 7.12 |
| 2026-01 | 0 | 5.95 |
| 2026-02 | 0 | 3.8 |
| 2026-03 | 1 | 3.48 |
| 2026-04 | 0 | 3.97 |
| 2026-05 | 0 | 6.61 |
| 2026-06 | 0 | 3.1 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-12-19 | Z-1017-2026 | Class II | Open, Classified | There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD, MO, MT, NV, NY, OH, OR, PA, PR, TX, VA, and WI. | 34 systems | code info di |
| 2025-10-16 | Z-0327-2026 | Class II | Open, Classified | Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.Distribution: US distribution to Ohio and Nevada | 2 units | clearance family |
| 2024-05-10 | Z-2041-2024 | Class II | Open, Classified | The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.Distribution: US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ, IL, OK, CA, FL, GA, OR, IN, NJ, CO, MT, KS, MO, WY, VA, VT, LA, NH, WV, TN, PR | 153 | code info di |
| 2021-05-21 | Z-2047-2021 | Class II | Open, Classified | The MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire.Distribution: US Nationwide distributions in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY. | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-24 | 2020563-2026-00003 | Injury | Available | exact di |
| 2025-05-09 | 2020563-2025-00004 | Injury | Available | exact di |
| 2024-10-16 | 2020563-2024-00008 | Injury | Available | exact di |
Regulatory clearances
- 510(k)K243335Substantially equivalent (SESE) · 2025-01-07clearance family
- 510(k)K241496Substantially equivalent (SESE) · 2024-08-20clearance family
- 510(k)K230355Substantially equivalent (SESE) · 2023-08-30clearance family
- 510(k)K222387Substantially equivalent (SESE) · 2022-08-31clearance family
- 510(k)K220192Substantially equivalent (SESE) · 2022-04-08clearance family
- 510(k)K212056Substantially equivalent (SESE) · 2021-08-04clearance family
- 510(k)K211037Substantially equivalent (SESE) · 2021-05-17clearance family
- 510(k)K203323Substantially equivalent (SESE) · 2021-03-04clearance family
- 510(k)K203553Substantially equivalent (SESE) · 2021-02-02clearance family
- 510(k)K192574Substantially equivalent (SESE) · 2020-03-09clearance family
- 510(k)K192506Substantially equivalent (SESE) · 2020-03-02clearance family
- 510(k)K183657Substantially equivalent (SESE) · 2019-03-15clearance family
- 510(k)K181593Substantially equivalent (SESE) · 2018-08-13clearance family
- 510(k)K173382Substantially equivalent (SESE) · 2018-01-26clearance family
- 510(k)K162183Substantially equivalent (SESE) · 2016-11-25clearance family
Predicate lineage
- K173382
Cited as predicate by: K181593
- K181593
- K183657
Cited as predicate by: K192506
- K192506
Cited as predicate by: K211037
- K211037
Cited as predicate by: K212056
- K220192
Cited as predicate by: K222387
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 |
|---|---|---|---|---|
| 2014-09-19 | NAI | No action indicated | Canon Components, Inc. (Factory Site) | 0 |
| 2014-09-17 | NAI | No action indicated | Canon Inc. | 0 |
| 2014-09-17 | NAI | No action indicated | Canon Inc. | 0 |
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