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.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-03-20 | Z-1584-2025 | Class II | Open, Classified | Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the deviceDistribution: U.S Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MO, NC, NY, OH, PA, PR, RI, TN, TX. | 281 | clearance family |
Regulatory clearances
- PMAP180032Approved (APPR) · 2025-12-18 · +19 earlier decisionsclearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2019-02-01 | NAI | No action indicated | Channel Medsystems, Inc. | 0 |
| 2019-02-01 | NAI | No action indicated | Channel Medsystems, Inc. | 0 |
| 2018-10-04 | VAI | Voluntary action indicated | Channel Medsystems Inc. | 0 |
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