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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96234

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

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Event summary

Timeline bucket
January 08, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ithera Medical 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

The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

Z-1100-2025
Recall number
Z-1100-2025
Initiated
January 08, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Ithera Medical Gmbh
Quantity
23 units (6 units US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Radiation Control for Health and Safety Act

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. The previous version of the user manuals contained a wrong value for the Nominal Ocular Hazard Distance (NOHD).

Code information

Model numbers MSOT Acuity Echo (Research System) MSOT Acuity Echo CE MSOT Acuity Echo CE2 UDI's: (01)04262380070004 (01)04262380070004(21)22102 (01)04262380070004(21)22203 (01)04262380070004(21)21901 (01)04262380070004(21)22101 (01)04262380070004(21)22104 (01)04262380070004(21)22105 (01)04262380070004(21)22106 (01)04262380070004(21)22107 (01)04262380070004(21)22201 (01)04262380070004(21)22202 (01)04262380070004(21)22204 (01)04262380070004(21)22205 (01)04262380070004(21)22206 (01)04262380070004(21)22301 (01)04262380070004(21)22401

Distribution pattern

Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.