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.
6 linked reportsMalfunction 4 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-03 | 0 | 2 |
| 2019-04 | 0 | 3.5 |
| 2019-07 | 0 | 1 |
| 2019-09 | 0 | 1.5 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-04 | 2 | 1.67 |
| 2020-06 | 2 | 2 |
| 2020-08 | 0 | 1.67 |
| 2020-10 | 0 | 2.5 |
| 2020-12 | 0 | 2.36 |
| 2021-01 | 2 | 2.67 |
| 2021-02 | 0 | 1.5 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 1.29 |
| 2021-06 | 0 | 1 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1.5 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 2 |
| 2021-12 | 0 | 1 |
| 2022-02 | 0 | 3 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1.33 |
| 2022-05 | 0 | 1.57 |
| 2022-06 | 0 | 1.38 |
| 2022-07 | 0 | 6 |
| 2022-09 | 0 | 1 |
| 2022-11 | 0 | 3.5 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1.5 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 1.45 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 4.5 |
| 2023-07 | 0 | 3 |
| 2023-09 | 0 | 3 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 3 |
| 2023-12 | 0 | 2.5 |
| 2024-03 | 0 | 2 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.25 |
| 2024-08 | 0 | 1 |
| 2025-01 | 0 | 1 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-10 | 0 | 1 |
| 2025-11 | 0 | 1.33 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-05 | 0 | 1.33 |
| 2026-06 | 0 | 1 |
Failure-mode summaryAI-generated
6 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-02-23 | Z-1462-2024 | Class II | Open, Classified | Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injuryDistribution: Worldwide distribution - US Nationwide and the countries of Canada, Argentina, Australia, Austria, Belgium, Chile, China, Colombia, Czech Republic, Finland, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Mexico, New Zealand, Norway, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Kingdom. | 541 units | clearance family |
| 2016-01-20 | Z-1698-2017 | Class II | Terminated | The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.Distribution: Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada. | 308 | clearance family |
| 2015-05-29 | Z-1745-2015 | Class II | Terminated | When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.Distribution: US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY. | 233 units | clearance family |
| 2014-06-06 | Z-2081-2014 | Class II | Terminated | When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.Distribution: USA (nationwide) including the states of AL, CA, FL, GA, IL, IN, IA, KY, LA, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, SC, TN, TX, VA, WV, WI, WY and Internationally to Canada. | 216 units | clearance family |
| 2014-05-13 | Z-2176-2014 | Class III | Terminated | Unit was mislabeled with a factory label showing 32 KW output power.Distribution: US in the state of WV | 1 | clearance family |
| 2013-05-15 | Z-1487-2013 | Class II | Terminated | Customers could potentially experience intermittent, unintended and illogical movement when using the product.Distribution: Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada | 104 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-01-28 | 11245025 | — | Available | catalog number |
| 2020-06-19 | 10173561 | Malfunction | Available | catalog number |
| 2020-04-30 | 10013343 | Malfunction | Available | catalog number |
Showing the most recent 3 of 6 linked reports.
Regulatory clearances
- 510(k)K103597Substantially equivalent (SESE) · 2011-01-03clearance family
Predicate lineage
Cited as predicate by: K141602, K161368, K172784, K180589, K183275, K191884, K193262, K212145, K213469
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
None in the loaded window.
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