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.
32 linked reportsMalfunction 32
| 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 | 3 | 2.08 |
| 2021-09 | 0 | 2.8 |
| 2021-10 | 0 | 2.13 |
| 2021-11 | 1 | 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 | 2 | 1.73 |
| 2023-03 | 0 | 1.78 |
| 2023-04 | 0 | 2.5 |
| 2023-05 | 0 | 2.8 |
| 2023-06 | 3 | 1.92 |
| 2023-07 | 0 | 2.3 |
| 2023-08 | 0 | 2.4 |
| 2023-09 | 1 | 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 | 4 | 2 |
| 2024-08 | 0 | 3.67 |
| 2024-09 | 0 | 4.75 |
| 2024-10 | 0 | 2.5 |
| 2024-11 | 3 | 1.7 |
| 2024-12 | 0 | 1.25 |
| 2025-01 | 0 | 1.6 |
| 2025-02 | 0 | 1.67 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 2.75 |
| 2025-05 | 3 | 1.75 |
| 2025-06 | 0 | 4.6 |
| 2025-07 | 0 | 5 |
| 2025-08 | 6 | 3.33 |
| 2025-09 | 0 | 2.67 |
| 2025-10 | 0 | 2.33 |
| 2025-11 | 3 | 3 |
| 2025-12 | 3 | 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
32 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 |
|---|---|---|---|---|
| 2025-12-16 | 3005899764-2025-00098 | Malfunction | Available | catalog number |
| 2025-11-14 | 3005899764-2025-00089 | Malfunction | Available | catalog number |
| 2025-08-28 | 3005899764-2025-00071 | Malfunction | Available | catalog number |
| 2025-08-07 | 3005899764-2025-00066 | Malfunction | Available | catalog number |
| 2025-05-16 | 3005899764-2025-00038 | Malfunction | Available | catalog number |
| 2024-11-01 | 3005899764-2024-00062 | Malfunction | Available | catalog number |
| 2024-06-28 | 3005899764-2024-00029 | Malfunction | Available | exact di |
| 2024-06-17 | 3005899764-2024-00027 | Malfunction | Available | catalog number |
| 2023-09-01 | 3005899764-2023-00042 | Malfunction | Available | exact di |
| 2023-06-07 | 3005899764-2023-00028 | Malfunction | Available | catalog number |
| 2023-02-15 | 3005899764-2023-00006 | Malfunction | Available | catalog number |
| 2021-11-11 | 3005899764-2021-00057 | Malfunction | Available | model number |
| 2021-08-26 | 3005899764-2021-00047 | Malfunction | Available | catalog number |
Showing the most recent 13 of 32 linked reports.
Regulatory clearances
- 510(k)K190103Substantially equivalent (SESE) · 2019-04-05clearance family
- 510(k)K172754Substantially equivalent (SESE) · 2018-02-09clearance family
- 510(k)K172319Substantially equivalent (SESE) · 2018-01-18clearance family
- 510(k)K162413Substantially equivalent (SESE) · 2017-03-31clearance family
- 510(k)K160433Substantially equivalent (SESE) · 2016-07-06clearance family
- 510(k)K131120Substantially equivalent (SESE) · 2013-07-16clearance family
- 510(k)K120632Substantially equivalent (SESE) · 2012-06-26clearance family
- 510(k)K112813Substantially equivalent (SESE) · 2011-12-01clearance family
- 510(k)K112760Substantially equivalent (SESE) · 2011-11-22clearance family
- 510(k)K102330Substantially equivalent (SESE) · 2011-08-12clearance family
Predicate lineage
Cited as predicate by: K103226, K112760, K112813, K120632, K131120, K140498, K140499, K160433, K162413, K172319, K172749, K172754, K172755, K211895, K231893
- K131120
Cited as predicate by: K140498, K141163, K160433, K162413, K172319, K172749, K172754, K172755
- K160433
- K162413
- K172319
- K172754
Cited as predicate by: K172755
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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