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 reportsMalfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3 |
| 2019-02 | 0 | 2.83 |
| 2019-03 | 0 | 3 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.4 |
| 2019-06 | 0 | 1.4 |
| 2019-07 | 0 | 3.67 |
| 2019-08 | 0 | 3 |
| 2019-09 | 0 | 2.4 |
| 2019-10 | 0 | 3.8 |
| 2019-11 | 0 | 3 |
| 2019-12 | 0 | 4.33 |
| 2020-01 | 0 | 2.17 |
| 2020-02 | 0 | 4 |
| 2020-03 | 0 | 1.71 |
| 2020-04 | 0 | 3.14 |
| 2020-05 | 0 | 1.8 |
| 2020-06 | 0 | 3 |
| 2020-07 | 0 | 2.29 |
| 2020-08 | 0 | 2 |
| 2020-09 | 0 | 2.5 |
| 2020-10 | 0 | 2.33 |
| 2020-11 | 0 | 2.5 |
| 2020-12 | 0 | 1.6 |
| 2021-01 | 0 | 2.33 |
| 2021-02 | 0 | 3.5 |
| 2021-03 | 0 | 2.43 |
| 2021-04 | 0 | 4.5 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 2.83 |
| 2021-08 | 0 | 2.08 |
| 2021-09 | 0 | 2.8 |
| 2021-10 | 0 | 2.13 |
| 2021-11 | 0 | 2.13 |
| 2021-12 | 0 | 2.57 |
| 2022-01 | 0 | 2.5 |
| 2022-02 | 0 | 1.17 |
| 2022-03 | 0 | 3 |
| 2022-04 | 0 | 2.4 |
| 2022-05 | 0 | 2.88 |
| 2022-06 | 0 | 1.83 |
| 2022-07 | 0 | 2.67 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1.86 |
| 2022-10 | 0 | 1.63 |
| 2022-11 | 0 | 1.88 |
| 2022-12 | 0 | 3.17 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1.73 |
| 2023-03 | 0 | 1.78 |
| 2023-04 | 0 | 2.5 |
| 2023-05 | 0 | 2.8 |
| 2023-06 | 0 | 1.92 |
| 2023-07 | 0 | 2.3 |
| 2023-08 | 0 | 2.4 |
| 2023-09 | 0 | 1.56 |
| 2023-11 | 0 | 1.5 |
| 2023-12 | 0 | 2.75 |
| 2024-01 | 0 | 1.33 |
| 2024-03 | 0 | 1.25 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 1.5 |
| 2024-06 | 0 | 2 |
| 2024-08 | 0 | 3.67 |
| 2024-09 | 0 | 4.75 |
| 2024-10 | 0 | 2.5 |
| 2024-11 | 2 | 1.7 |
| 2024-12 | 0 | 1.25 |
| 2025-01 | 0 | 1.6 |
| 2025-02 | 2 | 1.67 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 2.75 |
| 2025-05 | 0 | 1.75 |
| 2025-06 | 0 | 4.6 |
| 2025-07 | 0 | 5 |
| 2025-08 | 0 | 3.33 |
| 2025-09 | 0 | 2.67 |
| 2025-10 | 0 | 2.33 |
| 2025-11 | 0 | 3 |
| 2025-12 | 0 | 1.71 |
| 2026-01 | 0 | 3.4 |
| 2026-02 | 0 | 5 |
| 2026-03 | 0 | 2.5 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 2.8 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2018-07-26 | Z-2959-2018 | Class II | Terminated | There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.Distribution: Worldwide Distribution: US(nationwide) and to countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Belarus, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Nepal, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Suriname, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam. | 2889 units | clearance family |
| 2017-09-28 | Z-0772-2018 | Class II | Terminated | Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.Distribution: Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Republic of Korea, Kuwait, Latvia, Malaysia, Mexico, Morocco, Myanmar, Panama, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, and Vietnam. | 406 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-02-27 | 3005899764-2025-00021 | Malfunction | Available | catalog number |
| 2024-11-08 | 3005899764-2024-00063 | Malfunction | Available | catalog number |
Showing the most recent 2 of 4 linked reports.
Regulatory clearances
- 510(k)K190917Substantially equivalent (SESE) · 2019-05-09clearance family
- 510(k)K182568Substantially equivalent (SESE) · 2019-01-03clearance family
- 510(k)K172319Substantially equivalent (SESE) · 2018-01-18clearance family
- 510(k)K162413Substantially equivalent (SESE) · 2017-03-31clearance family
- 510(k)K140498Substantially equivalent (SESE) · 2014-07-24clearance family
Predicate lineage
- K140498
- K162413
- K172319
- K182568
- K190917
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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