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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85593

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 23, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sonendo Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

GENTLEWAVE REF: FG-002-0001

Z-2162-2020
Recall number
Z-2162-2020
Initiated
October 23, 2019
Classification
Class II
Status
Terminated
Recalling firm
Sonendo Inc
Quantity
460 foot pedals

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The console would continue to run for extended period when the foot pedal was released.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The console would continue to run for extended period when the foot pedal was released.

Code information

Foot Pedal, P/N: 102-0186-001 of GENTLEWAVE REF: FG-002-0001 device: Lot#: RI18.00462, RI18.00719, RI18.01283, RI18.01608, RI18.02168, RI18.02608, RI18.02882, RI18.02898, RI18.02899, RI18.03196, RI18.03264, RI18.03700, RI19.00901, RI19.01330

Distribution pattern

U.S.: OR, CA, NY, SD, CO, AL, WA, IN, TX, NM, IL, NC, AZ, TN, KS, MT, FL, UT, OK, ID, OH, ME, WV, CT, GA, MO, MI, NE, KY, VT, ND, NJ, DC, LA, NY, MA, VA, MN, SC, MD, PA, NH, NV, NE, OR, MS, WI, AK, IA. No foreign consignees.