Recall Z-1100-2025 ยท REK Research Laser
Ithera Medical Gmbh
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.
| Date | Feb 7, 2025 (initiated Jan 8, 2025) |
| Status | Open, Classified |
| Reason | 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). |
| 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 safet |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.