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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95233

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

Open FDA event record

Event summary

Timeline bucket
August 01, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Btt Health Gmbh

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

Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment

Z-3162-2024
Recall number
Z-3162-2024
Initiated
August 01, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Btt Health Gmbh
Quantity
62 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some power supply units in Austria and Germany had a voltage drop in the millisecond range, which led to a cancellation of the treatment and subsequent restart of the medical device. The treatment is only restarted by a step-off/step-on (step-on for activation).

Code information

serial numbers: 010426065891001421S05327911240506, 010426065891001421S05328011240506, 010426065891001421S05328111240506, 010426065891001421S05328211240506, 010426065891001421S05328311240506, 010426065891001421S05328411240506, 010426065891001421S05328511240506, 010426065891001421S05328611240506, 010426065891001421S05328711240506, 010426065891001421S05328811240506, 010426065891001421S05328911240506, 010426065891001421S05329011240506, 010426065891001421S05321911240430, 010426065891001421S05322011240430, 010426065891001421S05322111240430, 010426065891001421S05322211240430, 010426065891001421S05322311240430, 010426065891001421S05322411240430, 010426065891001421S05322511240430, 010426065891001421S05322611240430, 010426065891000721S05336411240521, 010426065891000721S05336511240521, 010426065891000721S05336611240521, 010426065891000721S05336711240521, 010426065891000721S05336811240521, 010426065891000721S05336911240521, 010426065891000721S05337011240521, 010426065891000721S05337111240521, 010426065891000721S05337211240521, 010426065891000721S05337311240521, 010426065891000721S05337411240521, 010426065891000721S05337511240521, 010426065891000721S05337611240521, 010426065891000721S05337711240521, 010426065891000721S05337811240521, 010426065891000721S05337911240521, 010426065891000721S05338011240521, 010426065891000721S05338111240521, 010426065891000721S05338211240521, 010426065891000721S05338311240521, 010426065891000721S05338411240521, 010426065891000721S05338511240521, 010426065891000721S05338611240521, 010426065891000721S05338711240521, 010426065891000721S05338811240521, 010426065891000721S05338911240521, 010426065891000721S05339011240521, 010426065891000721S05339111240521, 010426065891000721S05339211240521, 010426065891000721S05339311240521, 010426065891000721S05339411240521, 010426065891000721S05339511240521, 010426065891000721S05339611240521, 010426065891000721S05339711240521, 010426065891000721S05339811240521, 010426065891000721S05339911240521, 010426065891000721S05340011240521, 010426065891000721S05340111240521, 010426065891000721S05340211240521, 010426065891000721S05340311240521, 010426065891000721S05340411240521, 010426065891000721S05340511240521

Distribution pattern

US Nationwide distribution in the states of Florida.

Field note

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