Z-1100-2025Class II

The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of...

Name: Z-1100-2025 The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of...
Creator: Ithera Medical Gmbh
Published: 2025-01-08
License: https://open.fda.gov/license/

Ithera Medical GmbH / initiated 2025-01-08 / Open, Classified

FDA source

Ithera Medical Gmbh began a recall of 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... on 2025-01-08. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1100-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-08
Posted: 2025-02-07
Recalling firm: Ithera Medical GmbH
Product: 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.
Product code: REK Research Laser
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).
FDA root cause: Radiation Control for Health and Safety Act
Action: The firm sent an "Urgent Field Safety Notice" letter dated 12/19/2024 to its consignees. FSN 3746 has been distributed to all customers to correct a wrong value in the user manual for the NOHD. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: Take note of amendment/reinforcement of Instructions For Use (IFU) 1. Confirm the receipt of this FSN 2. Forward this information and the updated IFU to the person responsible for laser safety at your location (such as Laser Safety Officer) 3. The person responsible for laser safety at your location performs a new assessment of the laser safety consideration and to identify any additionally required work safety related measures 4. Training of all users of the MSOT Acuity Echo device on any additionally required work safety related measures, if applicable. The new calculation of the NOHD resulting in a higher value due to the use of a different calculation method. The user manual has been updated accordingly, and users have been informed. iThera will provide an updated user manual (IM_2.03_EN_III) with the corrected value for NOHD. If you have any questions, call 203-997-5110 US, +49-80-700749; EXT21 OUS or email: [email protected].
Quantity in commerce: 23 units (6 units US)
Distribution: Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1100-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1100-2025	Class II	Ongoing	FDA Mandated	2025-02-19	2025-02-07

Product code REK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)