Z-1100-2025 Class II Ongoing
FDA device recall Z-1100-2025 was initiated by Ithera Medical Gmbh on January 8, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 23 units (6 units US).
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2025
- Initiation Date
- January 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 23 units (6 units US)
Product Description
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.
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).
Distribution Pattern
Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.
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