The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered com
Summary
The FDA issued a Class II for The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mob by Ithera Medical Gmbh. 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 w.
Details
Source
Device Recall
External ID
Z-1100-2025
Action Date
2025-02-19
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 23 units (6 units US)
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
Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom.
Type: FDA Mandated
Recall Initiated: 2025-01-08
Company
Munich
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ithera Medical Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ithera Medical Gmbh have FDA actions?
This is the only FDA action we have on record for Ithera Medical Gmbh in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1100-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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