| Date Initiated by Firm | January 08, 2025 |
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| Date Posted | February 07, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1100-2025 |
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| Recall Event ID |
96234 |
| Product Classification |
Research laser - Product Code REK
|
| 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. |
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| 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 |
| FEI Number |
3011440527
|
Recalling Firm/
Manufacturer |
Ithera Medical Gmbh
Zielstattstr. 13
Munich Germany
|
Manufacturer 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). |
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FDA Determined
Cause 2 | Radiation Control for Health and Safety Act |
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| 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: josef.konardl@ithera-medical.com. |
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| Quantity in Commerce | 23 units (6 units US) |
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| Distribution | Worldwide distribution: US (Nationwide) and OUS (foreign) to countries of: Austria, Germany, Italy, Netherlands, Portugal, Switzerland, and United Kingdom. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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