Ithera Medical Gmbh recall records

1 reported ongoing

1 records in this archive. Latest source date Jan 8, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 ...

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).

Class IIReported ongoing

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

Official source for The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of e...

Reasons in these listed records

  • 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 examples come from this result page and are not a ranking of every recall reason.

Checking Ithera Medical Gmbh

Is there a recall on ithera medical gmbh right now?

This archive contains 1 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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